16

STABILITY STUDY OF TRIPHALA CHURNA PREPARED
FROM TWO GEOGRAPHICAL SOURCES KEPT IN SEALED

& UNSEALED CONTAINER AT ROOM TEMPERATURE
Dissertation submitted to
KLE UNIVERSITY, BELAGAVI
[Re-Accredited A Grade by NAAC || Placed in category A by MHRD (GoI)]
In partial fulfillment of the requirements for the degree of
M.D (AYURVEDA VACHASPATI)

In
RASASHASTRA & BHAISHAJYA KALPANA
By,
Dr. PRASHANT KUMAR SINGH B.A.M.S.
(Registration No: KB0113004)
Under the Guidance of
Dr. R. R. HIREMATH M.D (Ayu), Ph.D
Co-Guide :
Mr. AJIT C. LINGAYAT M.Sc(Medicinal Plant)
DEPARTMENT OF RASASHASTRA & BHAISHAJYA KALPANA
KLE University Shri B M Kankanawadi Ayurved Mahavidyalaya,

Shahapur, Belagavi
July 2016
i
UNDERTAKING
I, Dr. PRASHANT KUMAR SINGH hereby declare that the

information and the data mentioned in my dissertation entitled
STABILITY STUDY OF TRIPHALA CHURNA PREPARED FROM
TWO GEOGRAPHICAL SOURCES KEPT IN SEALED &
UNSEALED CONTAINER AT ROOM TEMPERATURE belongs to
me and is original.
I am aware of definition of plagiarism as detailed below:
An act or instance of using or closely imitating the language and

thoughts of another author without authorization and the
representation of that authors work as ones own, as by not crediting
the original author.
A piece of writing or other work reflecting such unauthorized use or
imitation.
The deliberate or reckless representation of anothers words, thoughts
or ideas as ones own without attribution in connection with
submission of academic work, whether graded or otherwise.
I hereby declare that the dissertation prepared by me is original-

one and does not involve plagiarism anywhere. In case at a later stage
it is found that I have indulged in plagiarism, then I am solely
responsible for the same and the Institution is at liberty to take any
disciplinary action against me including cancellation of dissertation or
any other penalties imposed by the University.
____________________
Date: Signature of the Research Scholar
Place: Belagavi
ii
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH,
(KLE DEEMED UNIVERSITY)

[Declared as Deemed-to-be-University u/s 3 of the UGC Act, 1956 vide Govt. of India Notification No.F.9-19/2000-
U.3 (A)]
(Re-Accredited A Grade by NAAC)
[Placed in Category A by MHRD (GoI)]
BELAGAVI
Copyright DECLARATION
We hereby declare that KLE ACADEMY OF HIGHER EDUCATION
AND RESEARCH, BELAGAVI, KARNATAKA shall have the rights
to preserve, use and disseminate this dissertation in print or electronic
format for academic/research purpose.
Signature Signature
Name of Research Scholar Name & Designation of Research Guide
Dr. Prashant Kumar Singh Dr. R.R.Hiremath, MD (Ayu), Ph D
Reader
Place: Belagavi
Date:
BELAGAVI
iii

[Declared as Deemed-to-be-University u/s 3 of the UGC Act, 1956 vide Govt. of India Notification No.F.9-
19/2000-U.3 (A)]
BELAGAVI
DECLARATION
I hereby declare that the dissertation entitled STABILITY STUDY
OF TRIPHALA CHURNA PREPARED FROM TWO

GEOGRAPHICAL SOURCES KEPT IN SEALED & UNSEALED
CONTAINER AT ROOM TEMPERATURE is a bonafide and
original research carried out by me under the guidance of
Dr. R.R.HIREMATH M.D (Ayu) Ph.D K.L.Es Shri B.M.K
Ayurveda Mahavidyalaya, Shahapur, Belagavi. The dissertation
or any part thereof has not formed the basis for the award of any
degree / fellowship or similar title to any candidate of any
University.
Place: Belagavi Signature

Date: Name & Address of the Research Scholar
Dr. Prashant Kumar Singh
KLEU BMK Ayurveda Mahavidyalaya, Shahapur,
Belagavi, Karnataka
iv

19/2000-U.3 (A)]
BELAGAVI
Certificate
This is to certify that the dissertation entitled STABILITY
STUDY OF TRIPHALA CHURNA PREPARED FROM TWO
GEOGRAPHICAL SOURCES KEPT IN SEALED &
UNSEALED CONTAINER AT ROOM TEMPERATURE is a
bonafide record of original research carried out by Dr. PRASHANT
KUMAR SINGH for the partial fulfillment of the requirement for
degree of M.D(Ayurveda Vachaspati) in RASASHASTRA
AND BHAISHAJYA KALPANA under my supervision.
Place: Belagavi Signature
Date: Name & Address of Guide

Dr. R.R.Hiremath, MD (Ayu), PhD
Reader,
KLEU BMK Ayurveda Mahavidyalaya,
Shahapur, Belagavi.
v
19/2000-U.3 (A)]

BELAGAVI
ENDORSEMENT BY THE HOD & PRINCIPAL OF THE

INSTITUTION
This is to certify that this dissertation entitled STABILITY

STUDY OF TRIPHALA CHURNA PREPARED FROM TWO
GEOGRAPHICAL SOURCES KEPT IN SEALED & UNSEALED
CONTAINER AT ROOM TEMPERATURE is a bonafide and
genuine research work carried out by Dr. Prashant Kumar Singh,
Department of Rasashastra & Bhaishajya Kalpana under the guidance
of Dr. R.R.Hiremath M.D(Ayu),Ph.D. Reader, Department of
Rasashastra & Bhaishajya Kalpana, K.L.E.University Shri.
B.M.Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagavi.
HOD PRINCIPAL
Dr. R.S.HIREMATH M.D (Ayu) Ph.D Dr B.S.PRASAD M.D (Ayu), Ph.D

HoD, Rasashastra & Bhaishajya Kalpana Principal, KLEU BMK Ayurveda
KLEU BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi
Mahavidyalaya, Shahapur, Belagavi
Date: Date:
Place: Belagavi Place: Belagavi
vi
ACKNOWLEDGMENT
It bestows me an enormous pleasure to gratitude those persons who supported me
in every moment of my study, which made this work successful.
In this unforgettable moment of successful completion of the dissertation work, it
is with deep sense of gratitude. I bow to Almighty, My parents and ShriBasappanna.
Mallappanna.Kankanawadi, who blessed me to achieve this milestone.
I extend my sincere thanks to my guide Dr. R.R.HIREMATH M.D (Ayu), PhD
Reader KLEUs Shri B.M.K Ayurveda Mahavidyalaya, Shahapur,Belagavi for the
magnitude of her Guidance, encouragement, support and helpful suggestions throughout
the study which literally helped me to conduct my work successfully.
Its my pleasure to extend heartful sincere thanks to our beloved Principal Dr.
B.S.PRASAD M.D (Ayu), PhD Principal KLEUs Shri B.M.K Ayurveda Mahavidyalaya,
Shahapur,Belagavi who has encouraged and guided me in all aspects.
I express my deep sense of gratitude to my Co-Guide Mr. AJIT C.
LINGAYATM.SC. (Medicinal Plants) Asst. Prof. Dept. of Dravyaguna KLEUs Shri B.M.K
Ayurveda Mahavidyalaya, Shahapur,Belagavi;for his nonenervative timely guidance.
My sincere thanks to Dr. R.S. HIREMATH, HoD, Dept. of Rasashastra &
Bhaishajya Kalpana for his timely opinions which helped me for completion of this
work.
I express my deep sense of gratitude to Dr. Giridhar Vedantam.Prof,
department of Dravyaguna for his complete cooperation, support and encouragement &
remarkable suggestions.
I would like to express my immense thanks to my teachers Dr. P.G.JADAR,
vii
Dr. K.S.GUDAGNATTI, Dr. N.M.HAMPANNAVAR, Dr. R.V.KAMAT, Dr.
S.A.DODDAMANI for their timely opinions & co-operation during my dissertation
work.
I wish to express my gratitude to Dr. M.B.GUNDKALLE, MR.
BASAVRAJ DHARWAD & Mr. Ganesh for their support during the analytical &
microbiological studies.
Its a privilege for me to express my esoteric sense of in solventedness to my
parents Mr. R.D.SINGH & Mrs. NIRMALA SINGH & all my respected Uncles &
Aunties, my wife Mrs. NEELU SINGH, my Brothers & Sisters & my little daughter
baby SAUMYA.
Its My immense pleasure to express my gratitude to my Uncle Dr. BINOD
SINGH MD (Ayu) who has initiated me to study AYURVEDA & shown the way & carrier
in AYURVEDA.
Its my pleasure to thanks my batchmates Dr. AMOL A. BUDRUK, Dr.
DIVYABH, Dr. RAHUL RANJAN, Dr. RAHUL NIGAM & Dr. MIKHEL NAIK for
their excellent support throughout my study.
I expressed my profound thanks to Librarian, Smt. G.C.GULL, Smt. VAISHALI,
Mr. VINAYAK.
I am very thanksful to all who have helped me directly or indirectly for the
completion of my dissertation work.
Date: Signature of the Research Scholar
Place: Belagavi Name: Dr. PRASHANT KUMAR SINGH
PG Scholar
viii
TABLE OF CONTENTS
Sl No. Contents Page no.
1. INTRODUCTION 1-2
2. AIMS & OBJECTIVES 3
3. REVIEW OF LITERATURE 4-28
3.1 Drug Review 4-20
3.2 Basic Concept of Churna 20-24
3.3 Triphala Churna 25-26
3.4 Basic Concept of Stability 27-28
4. METHODOLOGY 30-75
4.1 Pharmaceutical Study 30-48
4.2 Analytical Study 48-75
5. RESULTS 74-85
6. DISCUSSION 86-88
7. SCOPE FOR FURTHER STUDY 89
8. CONCLUSION 90
9. SUMMARY 91
10. BIBLIOGRAPHY 92-95
11. ANNEXURES
ix
ABBREVIATION
% -- Percentage
AIA -- Acid Insoluble Ash
WAS -- Water Soluble Ash
ASE -- Alcohol Soluble Extractive
AV -- Ash Value
Gm -- gram
Hrs -- Hours
LOD -- Loss on Drying
ml -- millie litre
Sl.no. -- Serial Number
WSE -- Water Soluble Extractive Value
ASE -- Alcohol Extractive Value
TLC -- Thin Layer Chromatography
w/w -- Weight by weight
Wt. -- Weight
Tr.Ch.= Triphala Churna
x
List of tables
Sl.No. Contents Page No
1. Different varieties of Haritaki 05
2. Haritaki in different Nighantu and Samhita 06

3. Different Rasas in different parts of Haritaki 07
4. Triphala Churna in different Nighantu 25
5. Ingredients of Triphala churna and their quantity 31
6. Results of weight OF Haritaki Churna 35
7. Results of weight of Bibhitaki Churna 39
8. Results of weight of Amalaki Churna 43
9. Churna output of individual Drugs 44

10. Showing the Observation of Coarse Powder Preparation 46
11. Showing the Time & Room Temperature of Sitopaladi 46

churna variation throughout preparation
12. Levelling of Final Products of both Sample 47
13. Packaging Design of Final Products of both Sample 47
14. Study Design 49
15. details of Temperature and Humidity 49

16. Physico-Chemical Analysis Of Both place Raw Drugs 74
Sample
17. Preliminary Phytocochemical Screening Of Both place 75
Raw Drugs Sample
18. Preliminary Phytochemical Screening of Both place 76
Raw Drugs
19. Thin Layer Chromatography Of Both place Raw Drugs 77
20. Physico-Chemical Analysis Of Kathmandu 79-80
Sealed Triphala Churna
21. Physico-Chemical Analysis Of Kathmandu Unsealed 80
Tr.Ch.
22. Physico-Chemical Analysis Of Belgaum Sealed Tr.Ch. 80
23. Physico-Chemical Analysis Of Belgaum Unsealed 81
xi
Tr.Ch.
24. Thin Layer Chromatography of all samples 82
25. Preliminary Phytocochemical Screening (Organic 83
Constituents) Of Kathmandu Sample
26. Preliminary Phytocochemical Screening (Organic 84
Constituents) Of Belgaum Sample
27. Preliminary phytochemical screening (Inorganic 85
Constituents) of Kathmandu Sample
28. Preliminary phytochemical screening (Inorganic 85-86

Constituents) of Belgaum Sample
xii
Abstract
ABSTRACT
Introduction: Bhaishajya Kalpana describes various types of dosage forms mainly
prepared from herbal ingredients. Here, Plants as a whole or their parts are subjected to
certain processes like grinding, triturating etc. to obtain Ayurvedic preparations viz
Vati, Churna, Swarasa, etc. The fine sieved powder of well-dried drug(s) is called
Churna. As Churna kalpana is one of the important dosage of Bhaishajya kalpana,
hence stability study of Churna was selected in present study. Among various Churna
preparations, Triphala Churna is used 90%in Ayurvedic medicine either directly as
medicine or for the preparation of other Ayurvedic preparations like Ghrita, Vati etc. It
is prepared by combination of dried fruit pulps of Haritaki, Vibhitaka and Amalaki in
equal proportion.
In this study, Triphala churna was prepared from two Geographical
sources. Their physico- chemical analysis was done at different levels when stored in
sealed and unsealed container.
Aim & Objective: Stability study of Triphala Churna prepared from two
Geographical sources kept at room temperature in sealed and unsealed containers.
Methodology: Herbal drugs were collected from natural habitat of Belagavi region
and Kathmandu region; Preparation of individual churna were carried out at KLE
Ayurveda Pharmacy & preparation of final product i.e. Triphala Churna was done in
CRF under sterilization condition - Ayush Approved Drug Testing Laboratory,
K.L.E.U. Sri BMK Ayurveda Mahavidhyalaya. Storage of Samples for Stability
Study was kept in Central Research Facility.

Abstract
Analytical: Analytical study was carried out at Ayush Approved Drug Testing
Laboratory, K.L.E.U. Sri BMK Ayurveda Mahavidhyalaya and Quality Control
Laboratories ALN Rao Memorial Ayurvedic Medical College & PG Centre, Koppa,
District: Chikmagalur, Karnataka
Result & Discussion: There were no more difference in Organoleptic characters,
Physico chemical analysis, Phytochemical study, Bulk Density, Flow rate &
Quantitative analysis of final products during interval of one year.
1. Preliminary physico chemical screening:
a. Preliminary physico-chemical screening indicated presence of inorganic
compounds Sodium, Iron, Phosphate, Chloride, Nitrate & Sulphate was present till 6
months of all samples but Sulphate was absent in 9 month & 12 months all samples
may be due to absence of Sulphate in Ash.
b. Preliminary phto-chemical screening indicated presence of inorganic compounds
Carbohydrate, Proteins, Amino Acids, Tannins & Phenolic Compounds, Steroids,
Alkaloids, Flavonoids & Monosaccharaides was present in all samples till one year.
2. Microbial study:
a. Total microbial load: In all condition value showed under limit.[I.P].
b. Microbial limit test:
In both samples (Triphala Churna of Kathmandu & Belgaum) Total Bacterial Count
(TBC) were within limits but in Total Fungal Count (TFC) at six month in all samples
it was TNTC.
Abstract
It was due to highly hygroscopic nature of the sample powders, and effect of
Moisture , much variance in Temperature & Humidity in comparison to other Month.

o o
(Season- August 2015- Temperature = 23.9 C+ 3.56 C & Humidity = 64 - 72 %)
3. Quantitative analysis screening:
Total Alkaloids & Total Tannins : Total alkaloids percentage values were seen few
variations due to climatic condition and also hygroscopic of nature of churna.
4. Stability study:
Results of 6th month physico chemical analysis and microbial load of all sample
showed variation compared to initial product and 3rd month sample due to climatic
change.
In TLC Rf. values of all sample 0 to 12th month showed negligible variation this
means extractive value was not more difference i.e. the stability in qualitative
perspective was not more differ.
Conclusion:
-Organoleptic characters of all samples of Triphala Churna were similar for the period
of 12 months.
-Minimum variations were observed in physico chemical analysis and microbial load ,
extractive values, Rf values in all samples of both conditions compared to initial
product for the period of 12 months.
-Kathmandu & Belgaum Sealed sample showed more stable in Percentage of Tannins
& Alkaloid.
Key Words: Triphala Churna, Sealed & Unsealed Container, Stability Study etc.
Introduction
1. INTRODUCTION
Bhaishajya Kalpana describes various types of dosage forms mainly prepared
from herbal ingredients. Here, Plants as a whole or their parts are subjected to certain
processes like grinding, triturating etc. to obtain Ayurvedic preparations viz Vati,
Churna, Swarasa, etc. Among these different preparations, some dosages are said to
be administer when prepared freshly like Swarasa. Some are said to become potent
when gets older like Asavarista. Other dosages are explained with particular shelf life
and storage conditions.
In Gazette of India, detail list is available about the shelf life of Ayurvedic
products. But this will be applied when the finished product is stored as per
specification, but how many days these products will retain their potency in unsealed
conditions is not available.
Because, some factors like storage and handling of the finished product leads
to contamination possibilities. Here, transferring bulk products to small containers
exposes the finished product to environmental conditions leads to microbial attack
and other environmental degradation which may alter the active components of the
products. The monitoring of the presence and concentration of the bioactive
constituents is extremely vital as it also affects the quality, efficacy and shelf-life of
the natural medicines. In case of herbal medicine containing a herbal drug preparation
with constituents of known therapeutic activity, the variation in content during the
proposed shelf-life should not exceed 5% of the initial assay value, unless justified1.
Stability study of Triphala Churna prepared from two Geographical sources kept
in Sealed & Unsealed Container at Room Temperature Page 1
Introduction
As Churna kalpana is one of the important dosage of Bhaishajya kalpana,
hence stability study of Churna is selected in present study. The fine sieved powder of
well-dried drug(s) is called Churna.
Among various Churna preparations, Triphala Churna is used 90%in
Ayurvedic medicine either directly as medicine or for the preparation of other
Ayurvedic preparations like Ghrita, Vati etc. It is prepared by combination of dried
fruit pulps of Haritaki, Vibhitaka and Amalaki in equal proportion.2
As per the official gazette, Shelf life of Churna is 2years3, i.e. when stored in
air tight container with proper precautions. The composition of herbs changes from
plant to plant. But whether those powders will remain same quality and strength after
opening the container and used is need of hour.
In this study, Triphala churna was prepared from two Geographical sources.
Their physico- chemical analysis was done at different levels when stored in sealed
and unsealed container.
Hence, present study was selected to evaluate the physico-chemical,
phytochemical & quantitative changes at 0, 3, 6, 9 and 12 months of two Triphala
Churna prepared from local (Belgaum) and Kathmandu source, stored in Sealed and
Unsealed container kept at room temperature.
Aims and Objective
2. AIMS AND OBJECTIVES
To evaluate physico-chemical analysis and microbial load of Triphala Churna
prepared from Local Source (Belgaum) at 0, 3, 6, 9 & 12 months kept at
room temperature in sealed and unsealed containers.
To evaluate physico-chemical analysis and microbial load of Triphala Churna
prepared from Kathmandu Source at 0, 3, 6, 9 & 12 months kept at room
temperature in sealed and unsealed containers.
Review of Literature
3. REVIEW OF LITERATURE
3.1. Drug Review
Haritaki 4
Botanical Name: Terminalia chebula Retz.
Natural Order: Combretaceae
Classical Names: Haritaki, Abhaya, Pathya, Kayastha, Putana, Haimavati, Avyatha,
Chetaki, Shiva, Vayastha, Rohini etc.
Vernacular Names 5 :
English : Chebulik myrobalan
Hindi : Hara, Harara, Harad, Harre, Sanghi-har, Hale-har, Pile-har
Nepali : Harro 6
Kannnad : Harra, Karakkayi, Aalekayi
Marathi : Hirda, Hirda-phula, Bala hirade
Assamese : Shilikha
Kashmiri : Halela
Malayalam : Katukka
Oriya : Harida
Punjabi : Halela, Harar
Tamil : Kadukkai
Telugu : Karaka, Karakkaya
Urdu : Halela
Stability study of Triphala Churna prepared from two Geographical sources

kept in Sealed & Unsealed Container at Room Temperature Page 4
Varieties:
In most of the Nighantus, Haritaki is of Seven varieties based on its lakshanas:
Table No.1 showing different varieties of Haritaki
VARIETY LAKSHANA UTPATTISTHANA PRAYOGA
Vijaya Alabuvrutta Vindhaya Sarvarogahara
Chetaki Trirekha Himalaya Rechaka
Putana Sukshma, Sindhu Pralepa
Rohini Vrutta Pratyeka Sthana Vranarohini
Amruta Mamsala Champa Shodhanartha
Abhaya Pancharekha Champa Akshiroga
Jeevanti Swarnavarna Saurashtra Sarvarogahara
SYNONYMS 7,8,9,10,11,12,13,14:
Several synonyms are used for Haritaki in Nighantu. Naming of a drug is based
on the popular name, nature, available place, resemblance, veerya etc.
Haritaki , Abhaya , Pathya , Kayastha , Pootana , Amruta , Avyatha , Chetaki ,
Vayastha ,
Vijaya , Jeevanti , Jeevapriya , Jeevanika , Jeevya , Jaya , Rohini , Pranada , Nandini ,
Chetanika , Prapathya , Vahninetra , Kashaya , Rechaki , Bhishagvara , Bhishakpriya
, Haimavati , Shakrasrshta , Shreyasi , Shiva , Devi , Divya , Prathama & Vrutana etc.

Table No. 2 showing Haritaki in different Nighantu and Samhita 15,16,17,18,19:
SAMHITA / GANAS/VARGAS
NIGHANTU
Charaka Samhita Arshoghna, Kushtaghna, Kasaghna, Jwaraghna,

Prajasthapana, Vayasthapana varga
Sushruta Samhita Amalakyadi, Parushakadi, Triphala gana
Ashtanga Sangraha Parushakadi, Kushtagha, Hikka Nigrahana,

Kasaghna
Ashtanga Hridaya Parushakadi gana, Aushadha varga, Virechana gana
Saushruti Nighantu Mushkakadi, Vachaharidradi, Parushakadi, Mustadi
Bhavaprakasha Nighantu Haritakyadi Varga
Dhanwantari Nighantu Guduchyadi Varga
Raaj Nighantu Amradi Varga
Kaiyadeva Nighantu Aoushadi Varga
Table.No.3 Different Rasas in different parts of Haritaki 20,21:
Acc. to Bhava Acc.to Kaideva Acc.to Raaj

Rasa Prakash Nighantu Nighantu
Nighantu
Madhura Majja Majja Internal to Asthi
Amla Snayu Mamsa Mamsa
Tikta Vrunta Asthi Beejasthi
Katu Twacha Snayu Twak

Most of the authors have substantiated the tridoshanashaka property of Haritaki
as follows:
According to Bhava Prakash Nighantu:
Madhura, Tikta, Kashaya rasa Pittanashaka
Katu, Tikta, Kashaya rasa Kaphanashaka
Amla rasa Vatashamaka
According to Shaligrama Nighantu:
Madhura, Tikta, rasa Pittashamaka
Katu, Kashaya rasa Kaphashamaka
Amla rasa Vatashamaka
Botanical Description:
A tree, 15-24 m. high. Leaves ovate or elliptic with a pair of large glands at the top of
petiole. Flowers yellowish white, in terminal spikes. Drupes ellipsoidal, obovoid or
ovoid, yellow to orange- brown, sometimes tinged with red or black and hard when
ripe, 3-5 cm long, 5 ribbed on drying. Seeds hard, pale yellow.
Distribution:
It is found throughout the greater parts of India, from Ravi eastwards to West Bengal
& Assam, ascending to an altitude of 1500 m in the Himalayas, also in Bihar, Orissa,
Madhya Pradesh, Maharashtra, Deccan and South India.

Part Used: Fruit
Actions & Uses:
Fruits are astringent, sweet, acrid, bitter, sour, thermo genic, anodyne, anti-
inflammatory, vulnerary, alterant, stomachic, laxative, purgative, carminative,
digestive, anthelmintic, dentifrice, cardiotonic, aphrodisiac, antiseptic, diuretic,
febrifuge, depurative and tonic.
They are useful in wounds, ulcers, inflammations, skin diseases, leprosy,
stomatitis, hyperacidity and associated gastric disorders, anorexia, indigestion,
flatulence, constipation, haemorrhoids, jaundice, hepato-splenomegaly, other
abdominal diseases, helminthiasis, anaemia, delirium, pharyngitis, hiccough,
dyspnoea, cough, coryza, asthma, scrotal enlargement, urinary disorders, vesical and
renal calculi, soft chancre, seminal defects, cephalagia, narcosis, fainting, epilepsy,
ophthalmic diseases, intermittent fevers, cardiac disorders, filarial, obesity,
neuropathy, rheumatoid arthritis, whitlow, dandruff, general debility.
Ayurvedic Properties:
Rasa: Kashaya, Tikta, Madhura, Katu, Amla
Guna: Laghu, Ruksha
Veerya: Ushna
Vipaka: Madhura
Prabhava: Tridoshashamaka
Doshaghnata: Tridoshashamaka, especially Vatashamaka

Rogaghanata: Vatavyadhi, Shotha-vedanayuktavikara, Vrana, Mukharoga,
Kantharoga, Nadidaurbalya, Mastishkadaurbalya, Netrabhishyanda, Drishtimandya,
Indriyadaurbalya, Agnimandya, Shoola, Anaha, Gulma, Vibandha, Udararoga, Arsha,
Kamala, Yakritpleehavridhi, Krimiroga, Hriddaurbalya, Vatarakta, Raktavikara,
Shotha, Pratishyaya, Kasa, Swarabheda, Hikka, Shwasa, Prameha, Shukrameha,
Shwetapradara, Garbhashaya-daurbalya, Mootrakrichchhra, Mootraghata, Asmari,
Prameha, Kushtha, Visarpa, Twagdosha, Vishamajwara, Jeerna jwara.
Karma: Shothahara, Vedanasthapana, Vranashodhana, Vranaropana, Nadibalya,
Medhya, Chakshushya, Deepana, Pachana, Yakriduttejaka, Anulomana,
Mridurechana, Krimighna, Grahi, Shonitasthapana, Hridya, Kaphaghna, Srotah-
shodhana, Vrishya, Garbhashayashothahara, Prajasthapana, Mootrala, Kusthaghna,
Rasayana.
Doses: 3-6 gm.
Chemical Constituents:
Anthraquinone, Glycoside, Chebulinic acid, Tannic acid, Terchebin, Tetrachebulin,
Vitamin C (Fruits); Arachidic, Behenic, Linoleic, Oleic, Palmitic and Stearic acids
(Fruit kernels); Chebulin (Flowers); 2-a-hydroxymicromeric acid, Maslinic acid and
2-a-hydroxy Ursolic acid (Leaves)
Pharmacological Activities:
Antimicrobial, antifungal, antibacterial, antistress, antispasmodic, hypotensive,
indurance promoting activity, anti hepatitis B virus activity, hypolipidaemic,
inhibitory activity, against HIV-1 protease, anthelmintic, purgative.

Substitutes & Adulterants:
Terminalia citrina Roxb. Ex Flem., found in the foothills of Himalayas from Nepal
eastwards to Assam is called Haritaki in Bengali language and its fruits have
medicinal properties similar to that of Terminalia chebula. Hence they are used
medicinally as those of T.chebula.
Research Articles:
1. Anil D.Mahajan et al /Int.J. ChemTech Res.2011,3(1)
In this study, an HPLC method for the qualification and quantification of phtyo
constituents in Haritaki churna has been developed and successfully applied for
comparison of three marketed samples (HC1, HC2, HC3). Significant variation in
phytochemical composition of these samples observed. The possible reasons for these
variations may be due to quality of the source materials which depend on several
factors like varietal selection, climatic and soil requirement, time of harvest, drying
parameter and post drying storage condition. The quality of formulation also depends
on how elements are handled in production processes i.e. improper and inadequate
mixing, variation in particle size.

2. Archana.D.et al /Int.J. PharmTech Res.2011,3(2)
In this study, Standardization of Haritaki as well as raw materials were done. The
results indicate that Haritaki contains a number of markers that may be responsible for
its therapeutic activity. The developed HPTLC method will assist in the
standardization of Haritaki using biologically active chemical markers. The marker
content of laboratory Haritaki was found higher than that of market samples of
Haritaki by HPTLC method, may be due to use of inferior quality of materials in the
preparation of tablets. The proposed Validated HPTLC method for Gallic acid and
rutin from Haritaki seems to be accurate, precise, reproducible and repeatable.
Haritaki also contained a number of other constitute, which are currently the subject
of further investigation,apart from those standards studied. Also profiles of the
individual components in Haritaki have been recorded as a standardization tool. With
the growing demand for herbal drugs and with increased belief in the usage of herbal
medicine, this standardization tool will help in maintaining the quality and batch to
batch consistency of this important Ayurvedic preparation.
Formulations & Preparations of Haritaki:
Abhayamodaka, Abhayarishta, Pathyadi Vati, Pathyadi kvatha, Vyaghriharitaki,
Haritaki leha, Triphala churna, Chitrakaharitaki, Agastiharitaki, Dantiharitaki,
Haritaki khanda, Pathyadi churna, Abhayadi guggulu, Abhayadi kalka,
Amritaharitaki, Abhayamalakiya rasayana etc.

Bibhitaki 22
Botanical Name: Terminalia bellirica (Gaertn.) Roxb.
Natural Order: Combretaceae
Classical Names: Bibhitaka, Aksha, Karshaphala, Kalidruma, Bhutavasa,
Kaliyugalaya.
Vernacular Names:
English - Belliric myrobalan.
Hindi - Baheda, Bhaira, Bulla, Behara.
Nepali Barro 6
Bengali - Bahera, Baheri, Bahira, Bahura.
Gujrati - Bahedamunjhad, Bahedo, Behaza, Beheda, Behedan, Bero, Behasa, Sag.
Kannnada - Behara, Tanrikayi, Santikayi, Tari, Yahela, Bherda.
Malyalam - Tanni, Tannikka, Thani.
Marathi - Bahera, Beheda, Bhirda.
Punjabi - Bahera, Bahira, Balela, Bayrah, Birha.
Tamil- Tanni, Tanrikkai, Tanikoi, Kattu-elupoe, Tani-kaia.
Telugu - Tandra, Tani, Thandi, Bahadrha.
Arab- Balilaj, Batilaj, Beleyluj.
Assam- Bauri, Hullach.

Distribution:
It is found in deciduous forests throughout the greater part of India, but not in the arid
regions, in areas of Upper Gangetic Plain, Chota Nagpur, Bihar, Orissa, W.Bengal,
Chittagong, Konkan, Deccan, S.M.Country and most of the parts of South India.
Part Used:
Fruit, seed, bark.
Actions & Uses:
The bark is mildly diuretic and is useful in anaemia and leucoderma. Fruits are
astringent, acrid, sweet, thermogenic, anti-inflammatory, anodyne, styptic, narcotic,
digestive, anthelmintic, aperient, expectorant, ophthalmic, antipyretic, antiemetic and
rejuvenating. They are useful in cough, asthma, bronchitis, pharyngitis, insomnia,
dropsy, dyspepsia, flatulence, dipsia, vomiting, cardiac disorders, haemorrhages,
ophthalmic disorders, haemorrhages, ophthalmic disorders, strangury, splenomegaly,
cephalagia, skin diseases, leprosy, fevers, ulcers and general debility. The mature and
dry fruit is constipating and is useful in diarrhoea and dysentery. The kernels possess
narcotic properties, eaten with betel nut and betel leaf for treatment of dyspepsia.
They are also useful in urinary calculus and eye diseases. The oil obtained from seeds
is trichogenous and is useful in dyspepsia, skin diseases, leucoderma and greyness of
hair.
Rasa: Kashaya

Guna: Ruksha, Laghu
Veerya: Ushna
Vipaka: Madhura
Doshaghnata: Tridoshashamaka, especially kaphashamaka
Rogaghanata: Shotha-vedanayuktavikara, Charmaroga, Granthi- visarpa, Hridroga,
Vrana, Netrabhishyanda, Vatavyadhi, Anidra, Adhmana, Trishna, Chhardi, Arsha,
Krimiroga, Vibandha, Atisara, Pravahika, Raktanishthivana, Ashmari, Klaibya, Jwara,
Samanya daurbalya, Netraroga.
Karma: Shothahara, Vedanasthapana, Raktastambhana, Krishnikarana, Madaka,
Deepana, Anulomana, Krimighana, Rechana, Bhedana, Grahi, Trishnanigrahana,
Chhardinigrahana, Kaphaghna, Vajikarana, Jwaraghna, Dhatuvardhaka, Chakshushya
Doses: 3-6 gm
Chebulagic acid, ellagic acid (also from bark, heartwood) and its ethyl ester, gallic
acid (also from seed coat); fructose, galactose, glucose and its galloyl derivative,
mannitol and rhamnose, B sitosterol and bellericanin (fruits); protein and oxalic acid
(seed); oxalic acid and tannins (bark); palmitic, oleic and linoleic acids (kernel and its
oil).

Purgative, blood pressure depressant, antifungal, antihistaminic, activity against viral
hepatitis and vitiligo, antiasthmatic, broncho-dilatory, anti-spasmodic antibacterial,
CNS stimulant, amoebicidal, antistress and endurance promoting activity.
Substitutes & Adulterants:
The bark of Terminalia bellirica Roxb. is used as adulterant to bark of Terminalia
arjuna W. & A. The fruits of Terminalia bellerica are reported to be used as
substitute in tanning industry for Terminalia chebula Retz.
Research Articles 22:
A clinical study was conducted on 50 cases of vitiligo with a compound herbomineral
preparation, viz., Ayush-57, containing Terminalia bellirica as one of the ingredients.
After 12 weeks of treatment 20 cases showed improvement. The results indicate
stimulation of pigment metabolism. However, no concrete conclusion was drawn as
the treatment required longer period and bigger samples to declare the utility of the
drug.
Formulations & Preparations:
Triphala churna, Triphala ghrita, Bibhitakadi kvath, Phalatrikadi kvath, Talisadi
churna, Lavangadivati.

Amalaki 23
Botanical Name: Emblica officinalis Gaertn./ Phyllanthus emblica Linn.
Natural Order: Euphorbiaceae
Classical Names: Amalaki, Vayasya, Vrishya, Dhatriphala, Amritaphala, Amalaka
Vernacular Names:
English - Emblic myrobalan, Indian gooseberry.
Hindi - Amalaki, Amalak, Amvala, Aonla, Amla.
Nepali Amala 6
Bengali - Amla, Amlaki, Ambolati, Amulati.
Gujrati - Bhosa, Amla, Ambala.
Kannad- Nellka, Nelli, Nilika.
Malyalam - Nellimaram, Nellikka, Boa-malacca.
Marathi - Avala.
Punjabi - Ambal, Ambli, Amla.
Tamil - Nelli, Nelli-kai, Toppi.
Telugu - Usirikaya, Amalakamu, Usereki, Wusheriko, Osirka, Usri, Usirika.
Arab- Amlaj.
Distribution:
Throughout tropical and subtropical India, chiefly in dry deciduous forests, ascending
to 1400 m on the Himalaya, Chota Nagpur, Bihar, Orissa, West Bengal, North
Circars, Deccan, Karnataka and in Western Ghats.
Part Used:
Fruit, Root bark, Stem bark, Leaf, Seed.

Actions & Uses:
The root bark is astringent and is useful in ulcerative stomatitis and gastric ulcer. The
bark is astringent and useful in gonorrhoea, jaundice, diarrhoea and myalgia. The
flowers are cooling and aperient. The leaves are useful in conjunctivitis,
inflammation, dyspepsia, diarrhoea and dysentery. The fruits are astringent, cooling,
anodyne, carminative, digestive, stomachic, laxative, alterant, alexeteric, aphrodisiac,
diuretic, antipyretic, tonic and trichogenous. They are useful in diabetes, cough,
asthma, bronchitis, headache, ophthalmic disorders, dyspepsia, colic, flatulence,
hyperacidity, peptic ulcer, erysipelas, skin diseases, leprosy, hematemesis,
inflammations, anaemia, emaciation, hepatic disorders, jaundice, strangury, diarrhoea,
dysentery, intrinsic haemorrhages, leucorrhoea, menorrhagia, cardiac disorders,
intermittent fevers and greyness of hair. Seeds are reported to be useful in asthma,
bronchitis and biliousness.
Rasa: Amla, Madhura, Kashaya, Tikta, Katu
Guna: Guru, Ruksha, Sheeta
Veerya: Sheeta
Vipaka: Madhura
Doshaghnata: Tridoshashamaka, especially Pittashamaka
Rogaghanata: Paittivikara, Daha, Paittikashirahshoola, Mootravarodha, Netraroga,
Khalitya, Palitya, Mastishkadaurbalya, Drishtimandya, Indradaurbalya, Aruchi,

Trishna, Agnimandya, Vibandha, Yakridvikara, Amlapitta, Parinamashoola,
Udavarta, Udararoga, Arsha, Hridroga, Raktapitta, Raktavikara, Kasa, Shwasa,
Yakshma, Shukrameha, Pradara, Garbhashayadaurbalya, Mootrakrichchhra,
Paittikaprameha, Kustha, Visarpa, Charmaroga, Jeernajwara,Kshaya, Daurbalya,
Daha, Shotha.
Karma: Dahaprashamana, Chakushaya, Keshya, Medhya, Nadibalya, Balya,
Rochana, Deepana, Anulomana, Amlatanashaka, Yakriduttejaka, Sthambhana,
Sransana, Hridya, Shonitasthapana, Kaphaghna, Vrishya, Garbhasthapana, Mootrala,
Pramehaghna, Kusthaghna, Jwaraghna, Rasayana.
Doses: Fruit powder- 3-6 gm.; Fresh juice- 10-20 ml.
A good source of Vitamin C; carotene, nicotinic acid, riboflavin, D-glucose, D-
fructose, myoinositol and a pectin with D- galacturonic acid, D- arabinosyl, D-
xylosol, L-rhamnosyl, D-glucosyl, D-mannosyl and D-galactosyl residues, embicol,
mucic, indole acetic acid and four other auxins- a1, a3, a4 and a5, two growth
inhibitors- R1 & R2; phyllembic acid and phyllembin (fruits) and fatty acids (seed
oil); ellagic acid, lupeol, oleanolic aldehyde and 0-acetyl oleanolic acid (root);
tannins, polyphenolic compounds; 1,2,3,6-trigalloylglucose, terchebin, corialgin,
ellagic acid, alkaloids, phyllantidine and phyllantine (leaves & fruits).

Spasmolytic, mild CNS depressant, hypolipidaemic, antiatherosclerotic,
antimutagenic, antimicrobial, antioxidant, immunomodulatory, antifungal, antitumor,
hypoglycaemic, anti-inflammatory, antibacterial, antiulcer, adrenergic potentating,
HIV-1 reverse transcriptase inhibitory action.
Research Articles 23:
AK MEENA et al.
- In this study, Preliminary phytochemical as well as various aspects of the

fruits sample
were studied and described along with physico-chemical, toxic heavy metal, aflatoxin
and TLC studies in authentification, adulteration for quality control of raw drugs.
The fruits of Emblica officinalis exhibit a set of diagnostic characters, which will help
to identify the drug in dried condition. It has been concluded from this study that
estimation of heavy metals and pesticides residue is highly essential for raw drugs or
plant parts used for the preparation of single and compound formulation drugs. The
periodic assessment is essential for quality assurance and safer use of herbal drugs.
Formulations & Preparations:
Brahmarasayana, Chyavanaprasha, Dhatrilauha, Dhatrirasayana, Triphala churna,
Amalakyavaleha, Amalakyadi kvath, Brihachchhagaladya ghrita, Phalarishta,
Dhatryaarishta.

3.2 Basic Concept of Churna:
General Descripition 24:
-Drugs according to the formulation composition of the particular Churna are
collected, dried, powdered individually and passed through sieve number 80 to
prepare a fine powder . They are mixed in the specified proportion and stored in well
closed container. The term Churna may be applied to the powder prepared by a single
drug or a combination of more drugs.
-Raja and Kshoda are the synonyms for Churna . Churnas may be of plant origin, or
mixed with other ingredients. The following points are to be noted. If metals /
minerals are used, prepare Bhasma or Sindura of the minerals unless otherwise
mentioned. In cases where Parada and Gandhaka are mentioned, prepare Kajjali and
add other drugs, one by one, according to the formula.
-In general the aromatic drugs like Hingu [Asafoetida] etc. should be fried before they
are converted to fine powders. Specific care should be taken in case of Salts and
Sugars. Formulations with hygroscopic components should not usually be prepared
during rainy seasons. If so, specific precautions should be taken during storage.
-Churnas should be stored in air tight containers. Polyethylene and foil packing also
provides damp proof protection. Special precaution for storage should be taken in
cases of formulations with salts, sugars and Ksharas .
- In industry, however, all the drugs are cleaned, dried and powdered together by

disintegrators. Mechanical sifters are also used. Salt, sugar, camphor etc., when
mentioned are separately powdered and mixed with the rest at the end. Asafoetida
(Hingu) and salt may also be roasted, powdered and then added. Drugs like Shatavari,
Guduchi, etc., which are to be taken fresh, is made into a paste, dried, and then added.
In our Classics Textbook:
Dravyamadraam Shilapistam Suskam wa sajala bhavet
Prakshepawakalakaste tanmaan karshasammitam 25
- When wet drug is pounded in khalva yantra, it leads to formation of soft
mass called as Kalka, where as shushka dravya forms Churna.
Atayanta sushka yata dravyam supistam vastra gaalitam
tata syata churna rajah kshoddastanamara karshasammita 26
- Completely dried drugs are pounded properly in Khalwa Yantra (Stone Mortar
& Pestel) and Gaalana (Filteration) should be done through a clean cloth. The
yield obtained is called Churna. Its dose is one karsha(12 g).
Sushka pistah sukshmtaantava vitchyuta churna
Tasya samsat dravyaaparityagaat plutoyogosha kalkad bhedah 27
- Shushka (Dried) kalka of drugs is also called as churna. When there is
nonavailabilty of fresh drugs so if we want to preserve the drug then Churna
method of preparation can be adopted.

Vernacular names:
Sanskrit Shushka, Kshoda, Rajah, Kalka, Shushka pista.
Hindi- Churna.
English- Powder.
Kannada- Pudi, Hittu, Churna.
Latin- Pulver, Pulverata.
Synonyms: Churna, Rajah (Pulvis), Kshoda (Powder).
Types of Churna:
A. According to Particle Size:
1. Sthula Churna- Course powder- for Hima, Phanta, Kashaya Sieved through No.
18-20.
2. Sukshma Churna- Fine Powder- for Vati, Lehya, Nasya- Sieved through No. 60.
3. Atayanta Sukshma Churna- for Bhasmas, Anjanas- Sieved through No. 120.
B. Single & Compound Formulations / Powders :
1. Ekala /Ekaushadha Churna (Single Formulation / Powder).
2. Mishra Churna (Compound Formulations / Powders).

Important Uses of Churna:
Churna can be used as main medicament in the treatment of many diseases.
Example, Triphala Churna, Avipattikar Churna etc.
Churna can be taken as Anupaana.
Churna can be taken for the preparation of other Kalpana like Vati, Arka,
Kasahya, Avaleha,Hima, Phanta etc.
Advantages of Churna:
Churnas are more stable than liquids, because chemical reactions take place
more rapidly when drugs are in liquid dosage form.
The rapid dissolution increases the blood concentration in a shorter time, there
by the action is produced in a lesser time.
It is easy to transport or carry the churnas and tablets than liquid dosage forms.
Incompatibility is less in case of churnas than in liquids.
Churnas are more easy to prepare and more economical compared to other
Dosage forms.
Disadvantages of Churna:
Volatile & hygroscopic drugs are not suitable for preparing &
dispensing in churna form.
Drugs which deteriorate on exposure to atmospheric conditions are not
suitable for dispensing.
Bitter, corrosive and unpalatable drugs cannot be dispensed in churna
form.

Prakshepaka Dravya along with Quantity & Sevena Vidhi 29 :
Guda- Equal of Churna.
Sarkara- Double quantity of Churna.
Hingu- Quantity that doesnt cause utkledana and used after frying with liquids.
Madhu & Ghrita- Double quantity of Churna.
Liquid for Frying- Ghee, Oil, Honey etc.- 2 Parts.
Milk & Water- 4 Parts.
Bhavana of Matra Dravya with Churna- The quantity of any liquid which soaks
the powder properly is called as Bhavana Dravya.
Dose: 1 Karsha (12 grams).
Shelf Life:
2 maasa (2 Months) -as Per Acharya Sharangadhar
2 Years- as per Ayurvedic Formulary of India / Gazette of India Part- 11,
Section 3 ( i).

3.3 Review of Triphala Churna
Triphala is a drug widely used in many disorders due to its various pharmacological
activities. Triphala is composed of three myrobalans, Terminalia chebula Retz.
(Haritaki), Terminalia bellerica Roxb. (Bibhitaki) & Emblica officinalis
Gaertn.(Amalaki) and is one of the most commonly used Ayurvedic preparations.
Table No.4 showing Triphala Churna in different Nighantu
Bhavprakash Nighantu Haritkyadi Varga
Kaideva Naighantu Aushadhi Varga
Madanpala Nighantu Abhayadi Varga
Sausrut Nighantu Parushkadi Gana
Triphala Churna 30,31 (Bhavaprakash, Haritkyadi Varga: 41-42)
Pathybibhitdhatrinam phalai syattriphala samai
Phalatrikancha triphala sa vara cha prakirtita ||41||
Triphala kaphapittaghani meha kusthahara sara
Chakshusya dipani ruchya vishamjwaranashini ||42||
- 1. Pathya (Haritaki) (P.) 1 Part
2. Bibhitaki (P.) 1 Part
3. Dhatri (Amalaki) (P.) 1 Part

Dose- 3 to 6 g
Anupana- Ghee, Honey, Warm Water.
Important Therapeutic Uses: Anaha (Distension of abdomen due to obstruction to
passage of urine and stools), Prameha (Urinary Disorders), Netra Roga (Eye disease),
Kaphapittaroga (Diseases due to kapha dosa & pitta dosa), Kustha (Diseases of skin),
Mandagni (Impaired digestive fire), Aruchi (Tastelessness), Vishamjvara (Intermittent
fever).
Research Article:
Niranjan Sonkar et. al. Vishwa Ayurveda Parishada, 10 year mar-apr 2013- In this
study , Pharmaceutical study of Haritaki Churna, Vibhitaki Churna, Amalaki Churna
and Triphala Churna retain their potency i.e. no deterioration is observed in terms of
physical, chemical and microbiological parameters after six month duration in the
RH 75% 5 and at temperature 45 0 C 2 C. Over all it can be concluded that the
trial drugs taken for study i.e. Haritaki Churna, Vibhitaki Churna, Amalaki Churna
and Triphala Churna retain their potency i.e. no deterioration is observed in terms of
physical, chemical and microbiological parameters after six month duration in the
RH 75%5 and at temperature 45 C2 C. This shelf life period may be applicable to
other churnas having similar method of preparation and constituents having similar
range of phyto-chemicals, carbohydrates, cellulose etc.
3.4 Basic Concept of Stability (Shelf Life) 32

Observation: All samples were observed for the duration of one year. The aim &
objective of stability testing is to provide evidence on how the drugs varies with time
under the influence of a variety of environmental factors such as Temperature,
Humidity, Light, Storing Condition.
Definition:
-Stability is officially defined as the time lapse during which the drug product retains
the same properties and characteristics that is possessed at the time of manufacture.
-The Stability of a product is expressed as the expiry period or technically as shelf life.
-The stability of finished pharmaceutical products depends, on the one hand, on
environmental factors such as ambient temperature, humidity and light, and, on the
other, on product-related factors, e.g. the chemical and physical properties of the active
substance and of pharmaceutical excipients, the dosage form and its composition, the
manufacturing process, the nature of the container-closure system and the properties of
the packaging materials For established drug substances in conventional dosage forms,
literature data on the decomposition process and degradability of the active substance
are generally available together with adequate analytical methods.
Need of Stability Study:
- Product instability of active drug may lead to under medication due to lowering
concentration of the drug in dosage form.
-During decomposition of active drug toxic products may be formed.
- Instability may be due to changing in physical appearance though the principles of
kinetics are used in predicting the stability of drug there different between kinetics
and stability study. The goal of chemical kinetics is to elucidate reaction mechanism,
In stability studies, the objective is to establish an establish an expiry date.

Types of Stability Study:
Five stabilities of drug must be considered
1. Physical stability
2. Chemical stability
3. Microbiological stability
4. Therapeutic stability
5. Toxicologic stability
1. Physical: The original physical properties, including appearance, palatability,
uniformity, dissolution and suspend ability are retained.
2. Chemical: Each active ingredient retains its chemical integrity and labeled potency
within the specified limits.
3. Microbiologic: Sterility or resistance to microbial growth is retained according to
the specified requirements. Antimicrobial agents retain effectiveness within specified
limits.
4. Therapeutic: The therapeutic effect remains unchanged.
5. Toxicologic: No significant increase in toxicity occurs.
Stability Study according to Objective:
1. Accelerated & Real Time Stability Study for Development of the product
& of the registration dossier. Quality assurance in general, including quality
control.
2. Short Term Stability Study for development of the product.
3. Accelerated Stability Study for the development of the product.

4. Real Time Stability Study for registration dossier.
FACTORS AFFECTING DRUG STABILITY
1. Temperature
2. PH
3. Moisture
4. Light
5. Concentration
1. Temperature- High temperature accelerates oxidation, reduction and hydrolysis
reaction which lead to drug degradation.
2. PH- Acidic and alkaline pH influences the rate of decomposition of most drugs.
Many drugs are stable between pH 4 and 8. Weekly acidic and basic drugs show good
solubility when they are ionized and they also decompose faster when they are
ionized. So if the pH of a drug solution has to be adjusted to improve solubility and the
resultant pH leads to instability then a way out of this tricky problem is to introduce a
water miscible Solvent into the product.
3. Moisture-
a. Water catalyses chemical reactions as oxidation, hydrolysis and reduction reaction.
b. Water promotes microbial growth.
4. Light- Affects drug stability through its energy or thermal effect which lead to
oxidation.
5. Concentration- Rate of drug degradation is constant for the solutions of the same
drug with different concentration. So, ratio of degraded part to total amount of drug in
diluted solution is bigger than of concentrated solution.

Concept of Climatic Zone (Two Geographical Sources)
Zone I 21C 45% RH
Zone II 25C 60% RH (Kathmandu, NEPAL)
Zone III 30C 35% RH (Belagavi, INDIA)
Zone IV 30C 65%RH
-My samples were prepared from two different Geographical Sorces.
Basically, there are three forms of Stability tests:
1. Physical & Chemical Integrity Test: which is for Evaluation of Colour,
Odour, pH Value, Viscosity, Texture, Flow and Emulsion Stability.
2. Microbiological Test: which is for evaluation of the degree of contamination
with Bacteria, Fungus, Mold & Yeast etc.
3. Packaging Stability Test: Which is for evaluation of the impact of packaging
on the product.
Research Articles:
1. Sangram kesari panda et.al - There are great need of standardization and
quality control of ayurvedic formulations. Standardization and quality control
depends upon the nature of crude drug and compound drugs, its source i.e.
factors associated with raw materials which are beyond of human control like
seasonal,geographical, age of the plant, time of collection, type of drying etc.

due to these natural conditions. the percentage of chemical constituents of the
drug does no remain uniform as our expectation.
2. B. Patgiri et. al. Evaluation of stability study of Ayurvedic formulation
Rasayana Churna
-The present investigation supports that the Rasayana Churna was suitable at
accelerated condition up to 6 month storage. it can be extrapolated that shelf
life of Rasayana Churna is 25.12 months (2.09 years) for countries which
comes under climatic zone I & II and 16.60 months (1.38 years) for countries
which comes under climatic zone III & IV. Real time stability data of
Rasayana Churna showed very good stability up to 1 year.
3. Anshuman et.al. Stability study of sitopaladi churna wsr to physico
chemical analysis and microbial load kept at different environmental
condition
- Grossly there was no much variation observed in results of samples stored in
sealed and unsealed in stability chamber and sealed condition in room temp. But
unsealed condition sample in room temp showed more variations may be due to
hygroscopic nature of powder, easy exposure to climatic conditions, more prone
to microbial growth.
4. Thorat Punam et.al. Stability Study of Dosage Form: an Inovative Step
- Pharmaceutical stability is a critical quality attribute. Any deviation from the
established stability profile could affect the quality, safety and efficacy.
-Thorough understanding of the stability of the drug substance and drug product is
important to build the quality in.

- Developing global stability programs are challenging due to climatic variations
and differences in local regulatory requirements
- Plan well and use science based approach; consult the experts/regulators, as
needed Stability studies should be planned on the basis of pharmaceutical R&D
and regulatory requirements. Forced degradation studies reveal the intrinsic
chemical properties of the API, while formal stability studies establish the retest
date. The shelf life (expiry date) of FPPs is derived from formal stability studies.
Variability and time trends of stability data must be evaluated by the manufacturer
in order to propose a retest date or expiry.

Methodology
4. MATERIALS AND METHODS
Source of data:
A. Literary data: was collected from Library (various Classical and Modern books),
Electronic data base (Scientific journals, and online research journals) and other
available sources of information.
B. Pharmaceutical: Herbal drugs was collected from natural Habitat of Belgaum
region and Kathmandu region; Preparation of individual churna was carried out
at KLEUS Ayurveda Pharmacy & preparation of final product i.e. Triphala
Churna was done in CRF - Ayush Approved Drug Testing Laboratory, K.L.E.U.
Sri BMK Ayurveda Mahavidhyalaya under sterilization condition.
C. Storage of Samples for Stability Study was kept in Central Research Facility
(CRF)- Ayush Approved Drug Testing Laboratory, K.L.E.U. Sri BMK Ayurveda
Mahavidhyalaya
D. Analytical: Analytical study was carried out at CRF- Ayush Approved Drug
Testing Laboratory, K.L.E.U. Sri BMK Ayurveda Mahavidhyalaya and Quality
Control Laboratories ALN Rao Memorial Ayurvedic Medical College & PG
Centre, Koppa, District: Chikmagalur, Karnataka
Methodology
PHARMACEUTICAL PART
4.1 RAW DRUG COLLECTION
Herbal drugs was collected from natural Habitat of Belgaum region and Kathmandu
region.
AUTHENTICATION:
Ayush Approved Drug Testing Laboratory, K.L.E.U. Sri BMK Ayurveda
Mahavidhyalaya.
4.2 Standarad Operative Procedure (SOP) of Triphala Churna:
Table no. 5 : Showing ingredients of Triphala churna and their quantity
Sl. Name of Latin name Part Ratio Quantity
No. Drug used
1. Haritaki Terminalia chebula Retz. Frt. 1 Part 200 Gram
2. Bibhitaki Terminalia bellirica (Gaertn.)Roxb. Frt. 1 Part 200 Gram
3. Amalaki Ebmlica officinalis Gaertn. Frt. 1 Part 200 Gram
Methodology
STANDARD OPERATING PROCEDURE OF INDIVIDUAL INGREDIENT
I. SOP of Haritaki Powder
Aim To prepare churna of raw Haritaki Reference Sh.Ma.Kh. 6/1
Principle Size Reduction
Date of commencement & completion 04 Feb.2015
Instruments & Equipments:
1. Pulverizer (Clint Mill 7.5 HP Motor)
2. Weighing machine
3. Mixer & jar
4. Steel vessel
5. Apron, mask, cap and disposable plastic gloves
6. Stainless steel spoon
7. Sieve no.80
8. Clean air tight plastic container
Standard Operative Procedure (SOP) consists of :
1) Pre operative Procedure
2) Operative
3) Post-operative Procedure
Methodology
1) Pre operative Procedure :
a. All the raw drugs were made free from foreign matter.
b. Drugs were dried completely.
c. Instruments and equipments needed for churna preparation were cleaned
and dried thoroughly.
d. Seeds were separated from ponded Haritaki.
2) Operative:
a. The dried official part of each drug were weighed as per specified quantity
and taken.
b. It was transferred to pulveriser having blade 3mm for powder formation.
c. Pulverized powder was sieved through 80 no. mesh through shifter.
d. Light Brown colour Powder was collected and stored in air tight container.
3) Postoperative:
1. Obtained sukshma churna were weighed.
2. Packed in air tight plastic bags.
Methodology
Precautions-
1. Drugs taken for the procedure were completely dried one.
2. The equipments was properly cleaned and dried before usage.
3. Hygiene was maintained during the procedure.
GENERAL OBSERVATIONS
a) Nature of Drug - Dry
b) Mesh size 80
c) Assessment Fine Powder
d) Temperature Room temperature
e) Duration of process 1 hour
f) Packaging and storage Packed in air tight packets.
Precaution:
o Weighing machine was calibrated before using.
o Sieve was cleaned properly before using.
o Haritaki seeds were removed completely.
Methodology
Table No. 6 Results of weight of Haritaki Churna
Name of the drug Initial weight Final weight after Total loss of
of raw drug Coarse powder weight
Haritaki (Kathmandu) 400 grams 226 grams 174 grams
Haritaki (Belgaum) 400 grams 220 grams 180 grams
Reason for loss-
Maximum loss was occurred during seed removal.
During Pulverizing for fine powder preparation minimal loss was occurred
due to mechanical errors & small sample size.(400 Gm only)
Similarly, the preparation oif Bibhitaki Churna & Amalaki Churna was done.
Table No.7 Results of weight of Bibhitaki Churna
Name of the drug Initial weight Final weight after Total loss of weight
of raw drug Coarse powder
Bibhitaki (Kathmandu) 400 grams 211 grams 189 grams
Bibhitaki (Belgaum) 400 grams 209 grams 191 grams
Methodology
TABLE No. 8 Results of weight of Amalaki Churna
Name of the drug Initial weight Final weight after Total loss of
of raw drug Coarse powder weight
Amalaki (Kathmandu) 400 grams 210 grams 190 grams
Amalaki (Belgaum) 400 grams 212 grams 188 grams
SOP OF TRIPHALA CHURNA
Name of Preparation : Triphala Churna
Reference AFI, Part 1, 7:15
Principle Mixing (To mix all the raw drug churna and prepare a homogenous
mixture)
Date of Commencement & Completion 04.02.2015
Table No. 9 showing Churna output of individual Drugs:
Name of the drug Initial weight of raw
drug
Haritaki (Kathmandu) 226 grams
Haritaki (Belgaum) 220 grams
Bibhitaki (Kathmandu) 211 grams
Methodology
Bibhitaki (Belgaum) 209 grams
Amalaki (Kathmandu) 210 grams
Amalaki (Belgaum) 212 grams
Instruments & Equipments:
a) Weighing Machine(Digital): (600g capacity) 01
b) Porcelain Mortar: 2 Kg. 01
c) Stainless steel Spoon (6 inch length): 01
d) Cap & Gloves
e) Sieve no and 80
f) Clean air tight plastic container
g) Method:
o All powders was taken as per specified quantity in a porcelain
mortar and triturated till homogenous mixture.
o After triturating powder was obtained and stored in air tight
container.
Observation:
o Appearance : Fine Powder
o Odour : Peculiar odour of Triphala
o Taste : Astringent
o Colour: Greyish Brown
Methodology
Precaution
o Porcelain Mortar was cleaned before pounding.
o Weighing machine was calibrated before using.
o Stainless steel spoon (size no.06) was cleaned before using.
o Air tight container was sterilised before using.
o Mixing was done carefully.
Nature of Drugs - Dry
Mesh size - 80 #
Assessment Sukshma churna
Finished product:
Powder was taken 50 gm in air tight container and kept in sealed and
unsealed condition.
Powder was kept in room temperature of both sources for fresh, 3, 6, 9 &
12 month.
Methodology
Table No.10 : Showing the Observation of Coarse Powder Preparation
Ingredient Form Color Touch Taste Smell
Haritaki Raw Light brown Medium Kashaya Characteristic
Coarse Light brown Medium Kashaya Characteristic
Bibhitaki Raw Light brown Medium Kashaya Characteristic
Coarse Light brown Medium Kashaya Characteristic
Amalaki Raw Dark brown Medium Amla Characteristic
Coarse Dark brown Medium Amla Characteristic
Table No.11: Showing the Time & Room Temperature of Triphala Churna
variation throughout preparation.
Period Time (month) Room temp. & humidity
Day 9:30 am (Feb 2015) 31oC+ 2oC & 44- 38 %
Night 7:30 pm(Feb 2015) 17oC+ 2oC & 40-36%
Methodology
Table No. 12 showing Levelling of Final Products of both Sample:
Stability Study of Triphala Churna Stability Study of Triphala Churna
Sample: Fresh Prepared Sample: Fresh Prepared
Belgaum Kathmandu
Date of Mfg: 06.02.2015 Date of Mfg: 06.02.2015
Date of opening: Date of opening:
Net Quantity: 50gm Net Quantity: 50gm
Student Name: Dr.Prashant Kr. Singh Student Name: Dr.Prashant Kr. Singh
Guide Name: Dr.R.R.Hiremath Guide Name: Dr.R.R.Hiremath
Co-Guide: Mr. Ajit C.Lingayat Co-Guide: Mr. Ajit C.Lingayat
Storage Condition:
A. Storage : Plastic sealed & unsealed container, free from direct sunlight exposure.
B. Temperature : Normal Room Temperature
C. Condition of Formulation : Sealed & Unsealed Plastic container of Triphal
Churna of Belagavi & Kathmandu two different geographical region.
Table No.13 showing Packaging Design of Final Products of both Sample:
Prepared Triphala Churna was packed in plastic containers each containing 50
gm.
Sealed Container- Aluminium Foil Sealing.
Unsealed Container- Without Foil.
Methodology
Triphala Churna Ktm Sample Bgm
Sample
10 Containers 50 Gram each with Seal 5 5
10 Containers 50 Gram each without Seal 5 5
Analytical Part
The term 'analyze' can be defined as to study something very closely and carefully. The
objective parameters for standardization is provided by Analytical study. It is a very tedious
job to standardize Ayurveda herbal formulations especially compound drugs because of their
complex chemical nature. By analytical study we can do the standardization of raw drugs &
final product for global acceptances & for Quality Assurance (QA) to get genuine drug not
an adulterated one. Maximum Formulations or Ayurvedic compounds contain multiple
ingredients, so fixation of particular standard or a marker component is a difficult job .
In spite of that, the research was undertaken to evaluate and to compare the formulation with
the available physico-chemical parameters, phyto-chemical parameters, TLC, Microbial
studies & some quantitave analysis such as Total Alkaloids Estimation & Total Tannins.
Hence, the analytical study of the drug was been carried out.
Study Design :
Analytical study was done of both samples of final products to evaluate Organoleptic
Characters, Physicochemical, Phytochemical , quantitative analysis and Microbial Tests.
Duration of Study : 12 Months (Long Term)
Testing Frequency : Every 3 month (0, 3, 6, 9, 12 month)
Methodology
Table No.14 Showing Study Design
Ktm Bgm
0 Month Initial Product Initial Product
Sealed Unsealed Sealed Unsealed
3rd month Done Done Done Done
6th month
9th month
12th month
Table No. 15 Showing details of Temperature and Humidity
Period Month Temperature Humidity
Initial product Feb 2015 30oC+ 2oC 40-46 %

o o
3rd month May- 2015 25.01 C+ 1.59 C 33-40 %
o o
6th month Aug-2015 23.9 C+ 3.56 C 64-72 %
o o
9th month Nov-2015 25.01 C+ 1.59 C 56-48 %
o o
12th month Feb-2016 27.03 C+ 1.5 C 52-44 %
AIM OF STUDY Physico chemical and phytochemical analysis of raw drugs Haritaki,
Bibhitaki and Amalaki of both Sources, Triphala Churna of both sources.
Methodology
I) Parameters selected for Analytical study of the raw drugs
1. Organoleptic Characteristics
Rupa(Colour) Gandha(Odour)
Rasa (Taste) Sparsha(Texture)
2. Physico Chemical Analysis
Loss on drying Water Soluble extractive
Ash value Alcohol soluble extractive
Acid Insoluble Ash
3. Preliminary Phytochemical Screening:
3.a. Tests for Inorganic Chemical Constituents:
Calcium Sodium
Magnesium Potassium
Iron Phosphate
Sulphate
Chloride
Carbonate
Nitrates
Methodology
3.b. Preliminary Phytochemical Screening
Tests for Organic Chemical Constituents :
1. Test of Carbohydrates
2. Test for Reducing sugar
3. Test for Monosacharides
4. Test for Pentose Sugar
5. Test for Protein
6. Test for Amino Acid
7. Tests for Steroids
8. Tests for Glycosides
9. Test for Alkaloids
10. Test for Flavonoid
4.Thin Layer Chromatography
II) Parameters selected for the Triphala churna (Finished product- from 0 month
to 12 month)
Description of the product (Color, Odor, Taste, Texture)
Methodology
Physicochemical analysis:
a. Moisture Content
b. Total Ash
c. Acid Insoluble Ash.
d. Water Soluble Ash
e. pH
Preliminary Phytochemical Studies
TLC
Bulk Density, Angle of Repose, True density & Flow Rate
Total Tannins Percentage
Estimation of Total Alkaloids
Microbial Load
Microbial Limit
- All the methodology was followed by Ayurvedic Pharmacopoeia of India (API)
& Indian Pharmacopoeia (IP).
1. Description of the Product
Various Organoleptic characters like Colour (Rupa), Taste (Rasa), Odour (Gandha),
Touch (Sparsha) was done by sensory profiles (Panchendriya Pariksha of Ayurveda).
Colour- Greyish Brown
Taste- Astringent
Methodology
Odour- Peculiar odour of Triphala
Touch- Fine Powder
2.Physico-Chemical Study-
A. SoP of Moisture Contents/ Loss on drying:-
- Weigh about 1.5 gm of the powdered drug into a weighed flat and thin porcelain dish.
- Dry in the oven at 100 C-105 C for around one hour.
- Cool in a Desiccator for 5 to 10 minutes.
- Weigh it and recorde the loss. The loss in weight is actually recorded as moisture.
Example,
Calculation of Moisture Contents of Haritaki- Ktm
Weight of Crucible = 25.8 gm
Weight of Haritaki = 1.5 gm
Weight of Haritaki + Crucible = 27.3 gm
After LoD at 105 C for one hour,
Weight of Haritaki + Crucible = 27.265 gm
Loss in weight of Haritaki = 0.035 gm
Percentage loss on drying = loss in weight of the sample X100 %
Weight of the sample taken
= 0.035 X100 % = 2.33 %
Methodology
B. SoP of Determination of Total Ash :
Incinerate about 2 to 3 g accurately weighed, of the ground drug in a tared
platinum or silica dish at a temperature not exceeding 450 until free from carbon,
cool and weigh. If a carbon free ash cannot be obtained in this way, exhaust the
charred mass with hot water, collect the residue on an ashless filter paper,
incinerate the residue and filter paper, add the filtrate, evaporate to dryness, and
ignite at a temperature not exceeding 450.
Example,
Calculation of Total Ash of Haritaki- Ktm
Weight of Crucible = 24.54 gm
Weight of Haritaki = 3 gm
Weight of Crucible +Ash = 24.638 gm
Weight of ash = 0.098 gm
Percentage of total ash = weight of ashX100
Weight of the sample taken
= 0.098 X 100 %
= 3.26 %
Methodology
C. SoP of Acid Insoluble Ash : Boil the ash obtained in Total Ash for 5 minutes
with 25 ml of dilute hydrochloric acid; collect the insoluble matter in a Gooch
crucible, or on an ashless filter paper, wash with hot water and ignite to constant
weight. Calculate the percentage of acid-insoluble ash with reference to the air
dried drug.
Example,
Calculation of Total Ash of Haritaki Churna- Ktm
Weight of Haritaki Churna = 3 gm
Weight of crucible= 35.46 gm
Final weight of crucible with acid insoluble ash = 35.53 gm
Weight of acid insoluble ash = Final weight of crucible with acid insoluble ash
weight of crucible
= 35.53-35.46
= 0.07
Percentage of acid insoluble ash = weight of acid insoluble ash
Weight of ash
= 0.07 X 100
= 2.33 %
Methodology
D. SoP of Water Soluble Ash : Boil the ash for 5 minutes with 25 ml of water;
collect insoluble matter in a Gooch crucible, or on an ashless filter paper, wash
with hot water, and ignite for 15 minutes at a temprature not exceeding 450.
Substract the weight of the insoluble matter from the weight of the ash; the
difference in weight represents the water-soluble ash. Calculate the percentage of
water-soluble ash with reference to the air-dried drug.
Example,
Calculation of Water Soluble Ash of Bgm fresh prepared sample.
Weight of Triphal Churna (Bgm) = 3 gm
Weight of crucible= 28.4 gm
Final weight of crucible with water soluble ash = 28.55 gm
Weight of acid insoluble ash = Final weight of crucible with acid insoluble ash
weight of crucible
= 28.55-28.4 gm
= 0.15 gm
Percentage of acid insoluble ash = Weight of acid insoluble ash X 100 %
Weight of ash
= 0.15 X 100 %
=5%
Methodology
E. SoP of Determination of Alcohol Soluble Extractive : Macerate 5 g of the air
dried drug, coarsely powdered, with 100 ml of Alcohol of the specified strength in
a closed flask for twenty-four hours, shaking frequently during six hours and
allowing to stand for eighteen hours. Filter rapidly, taking precautions against loss
of solvent, evaporate 25 ml of the filtrate to dryness in a tared flat bottomed
shallow dish, and dry at 105, to constant weight and weigh. Calculate the
percentage of alcohol-soluble extractive with reference to the air-dried drug.
Example,
Calculation of Alcohol Soluble Extract of Bgm fresh prepared sample.
Weight of Beaker = 46 Gm
Weight of Triphala Churna (Bgm- Fresh Prepared) = 5 Gm
Weight of Beaker + Extract = 46.53 Gm
Weight of Extract = 0.53 Gm
% of A.S.E. = Weight of Extract X 4 X 100 %
Weight of Drug (Sample)
= 0.53 X 4X 100 %
= 42.4 %
Methodology
F. SoP of Determination of Water Soluble Extract : Macerate 5 g of the air dried
drug, coarsely powdered, with 100 ml of chloroform water instead of ethanol in a
closed flask for twenty-four hours, shaking frequently during six hours and
allowing to stand for eighteen hours. Filter rapidly, taking precautions against loss
of solvent, evaporate 25 ml of the filtrate to dryness in a tared flat bottomed
shallow dish, and dry at 105, to constant weight and weigh. Calculate the
percentage of alcohol-soluble extractive with reference to the air-dried drug.
Example,
Calculation of Water Soluble Extract of Bgm fresh prepared sample.
Weight of Beaker = 32 Gm
Weight of Triphala Churna (Bgm- Fresh Prepared) = 5 Gm
Weight of Beaker + Extract = 32.65 Gm
Weight of Extract = 0.65 Gm
% of A.S.E. = Weight of Extract X 4 X 100 %
Weight of Drug (Sample)
= 0.65 X 4X 100 %
= 52 %
Methodology
G. SoP of pH Value :
The pH value of an aqueous liquidmay be defined as the common logarithum of
the reciprocal of the Hydrogen ion concentration expressed in Gm per Litre. It
provides a useful practical means for the quantitative indication of the acidity or
Alkalinity of a solution. The pH of the solution is analysed by pH analyser
(model) instrument. This pH meter should be calibrated and then the procedure to
calculate the pH is followed. The standard buffers for calibration are 4.2 & 9.0
Method:
Operate the pH meter and electrode system acc to manufacturers instructions.
Standardize the meter & electrodes with 0.05 M Potassium hydrogen phthalate
(pH 4.00) when measuring an acid solution or with 0.05 m sodium borate when
measuring an alkaline solution. At the end of a set of measurements take &
reading of the solution used to standardize the meter & electrodes. This reading
should not differ by more than 0.02 from original value at which the apparatus
was standardized.
Example,
Calculation of pH of Ktm Sealed of Fresh (0) to 12 months.
Ktm 0 Month 3 Month 6 Month 9 Month 12 Month
Sealed
Ph 4.41 4.05 4.02 4.25 4.2
Methodology
H. SoP of Flow Rate:
Bulk density (B) A. V. et al., JIPBS, Vol 2 (4), 494-505, 2015 497
It is defined as the mass of a powder divided by the bulk volume. It was being Pathak
determined by Fixed funnel method. A sample of 50 cm3 of powder that has been passed
through sieve no. 20 is carefully introduced into a 100 ml graduated cylinder. The
cylinder is dropped at 2 sec intervals on hard wooden surface three times from a height of
1 inch. The bulk density is obtained by dividing the weight of the sample in gm by the
final volume in cm3 of the sample contained in the cylinder.
Example: Fresh prepared Belgaum Triphala Churna calculation,
Sample wt. = 11.37 gm
Real Volume = 23
After 100 tapping,
Tapped Volume = 20
Bulk Density = Sample wt.
Tapped Volume
= 11.37
20
= 0.56
Methodology
SoP of True density (T) according to Subramanyam C.V in Text book of Physical
Pharmacy,
It is defined as the mass of the powder divided by the tapped volume. A powder sample
about 5.0g is transferred into the tarred 10 ml cylinder with the help of a funnel. The 250
ml measuring cylinder is placed on the tapping apparatus. The content is tapped and the
volume occupied is recorded. The ratio of mass of powder to the tapped volume
represents Tapped density.
Sample wt. = 11.37 gm
Real Volume = 23
After 100 tapping,
Tapped Volume = 20
True Density = Sample wt.
True Volume
= 11.37
20
= 0.49
Methodology
SoP of Angle of repose ()
A glass funnel is held in place with a clamp on ring support over a glass plate.
The glass plate is placed on a micro-lab jack. Approximately 100g of powder is
transferred in to the funnel which has been passed through number 10 size mesh,
keeping the orifice of funnel blocked by the thumb. The lab-jack is so adjusted so
that the gap of about 6-7 mm is maintained between top of powder pile and
bottom of funnel stem. When the powder is emptied from the funnel, the angle of
heap to the horizontal plane is measured with a protector. Measure the height of
the pile (h) and the radius of the base (r) with the ruler. The angle of repose is thus
estimated by the formula. = tan-1 ( h / r )
Height of beaker from ground = 2.5 cm
Radius = 7 = 3.5
Angle of Repose = h
= 2.5
3.5
= 0.71
Tan-1 0.71 = 35.37
Flow Rate = Fair- aid not needed
Methodology
2. Preliminary Phyto-Chemical Studies-
In Preliminary Phyto-Chemical Studies we have done Test for Inorganic
Elements & Organic Elements by following method-
Tests for Inorganic elements:
Prepared ash of drug material.
50% v/v of HCL was added to ash.
Kept for 1 hour.
That filtrate was use for following tests.
1. Test for Calcium: To filtrate, ammonia carbonate was added and observed for
white ppt for presence of calcium.
2. Test for Sodium: To filtrate, potassium pyroanthllollate was added and
observed for white ppt for presence of sodium.
3. Test for Potassium: To filtrate, sodium cobalt nitrate was added and observed
for yellow ppt for presence of potassium.
4. Test for Iron: To filtrate, ammonium thiocyanate was added and observed for
red color for presence of iron.
Methodology
5. Test for Chloride: To filtrate, Silver nitrate was added and observed for ,
white ppt of AgCl2 for presence of chloride.
6. Test for Sulphate: To filtrate, lead acetate was added and observed for white
ppt which is soluble in NaOH for presence of sulphate.
7. Test for carbonates: Take 2gm of ash and add 25% 2molar HCl , presence of
effervescence.
Tests for Organic elements:
1. Test of carbohydrates:
Molisshs Test (General Test),
Reducing Sugars (Benedictss Test)
Monosaccharides (Barfoeds Test)
Pentose Sugars ( Bials Test)
2. Test for protein
Millions Test
Methodology
3. Test for amino acid
Ninhydrin Test
4. Tests for steroids
Salkowski reaction
5. Tests for glycosides
Legalstest,Anthraquinone Glycosides, Saponin Glycosides ( Foam Test) flavonoids
6. Test for Alkaloids
Dragondroffs reagent
7. Test for tannins and phenolic compounds
Lead acetate.
Methodology
3. Thin Layer Chromatography (TLC)
Thin-layer chromatography is a technique in which a solute undergoes distribution
between two phases, a stationary phase acting through adsorption and a mobile phase in
the form of a liquid. The adsorbent is a relatively thin, uniform layer of dry finely
powdered material applied to a glass, plastic or metal sheet or plate. Glass plates are most
commonly used. Separation may also be achieved on the basis of partition or a
combination of partition and adsorption, depending on the particular type of support, its
preparation and its use with different solvent.
Identification can be effected by observation of spots of identical R value and about

f
equal magnitude obtained, respectively, with an unknown and a reference sample
chromatographed on the same plate. A visual comparison of the size and intensity of the
spots usually serves for semi-quantitative estimation.
Apparatus
(a)Flat glass plates of appropriate dimensions which allow the application at specified
points of the necessary quantities of the solution being examined and appropriate
reference solutions and which allow accommodation of the specified migration path-
length. The plates are prepared as described below; alternatively, commercially prepared
plates may be used.
(b)An aligning tray or a flat surface on which the plates can be aligned and rested when
the coating substance is applied.
(c) The adsorbent or coating substance consisting of finely divided adsorbent materials,
normally 5 m to 40 m in diameter, is suitable for chromatography. It can be applied
directly to the plate or can be bonded to the plate by means of Plaster of Paris (Hydrated
Methodology
Calcium Sulphate) or with any other suitable binders. The adsorbent may contain
fluorescing material to help in visualising spots that absorb ultra-violet light.
(d) A spreader which, when moved over the glass plate, will apply a uniform layer of
adsorbent of desired thickness over the entire surface of the plate.
(e) A storage rack to support the plates during drying and transportation.
(f) A developing chamber that can accommodate one or more plates and can be properly
closed and sealed. The chamber is fitted with a plate support rack that supports the plates,
back to back, with lid of the chamber in place.
(g)Graduated micro-pipettes capable of delivering microlitre quantities say 10 l and less.
(h)A reagent sprayer that will emit a fine spray and will not itself be attacked by the
reagent.
(i)An ultra-violet light, suitable for observation at short (254 nm) and long (365 nm)
ultra-violet wavelengths.
Preparation of plates Unless otherwise specified in the monograph, the plates are
prepared in the following manner. Prepare a suspension of the coating substance in
accordance with the instructions of the supplier and, using the spreading device designed
for the purpose, spread a uniform layer of the suspension, 0.25 to 0.30 mm thick, on a flat
glass plate 20 cm long. Allow the coated plates to dry in air, heat at 100 to 105 for at
least 1 hour (except in the case of plates prepared with cellulose when heating for 10
minutes is normally sufficient) and allow to cool, protected from moisture. Store the
plates protected from moisture and use within 3 days of preparation. At the time of use,
dry the plates again, if necessary, as prescribed in the monographs.
Methodology
Method
-Prepare the tank by lining the walls with sheets of filter paper; pour into the tank,
saturating the filter paper in the process, sufficient of the mobile phase to form a layer of
solvent 5 to 10 mm deep, close the tank and allow to stand for 1 hour at room
temperature. Remove a narrow strip of the coating substance, about 5 mm wide, from the
vertical sides of the plate.
-Apply the solutions being examined in the form of circular spots about 2 to 6 mm in
diameter, or in the form of bands (10 to 20 mm x 2 to 6 mm unless otherwise specified)
on a line parallel with, and 20 mm from, one end of the plate, and not nearer than 20 mm
to the sides; the spots should be 15 mm apart. If necessary, the solutions may be applied
in portions, drying between applications. Mark the sides of the plate 15 cm, or the
distance specified in the monograph, from the starting line. Allow the solvent to
evaporate and place the plate in the tank, ensuring that it is as nearly vertical as possible
and that the spots or bands are above the level of the mobile phase. -Close the tank and
allow to stand at room temperature, until the mobile phase has ascended to the marked
line. Remove the plate and dry and visualise as directed in the monograph; where a
spraying technique is prescribed it is essential that the reagent be evenly applied as a fine
spray.
For two-dimensional chromatography dry the plate after the first development and carry
out the second development in a direction perpendicular to the first.
-When the method prescribed in the monograph specified protected from light or in
subdued light it is intended that the entire procedure is carried out under these
conditions.
Methodology
Visualisation
The phrases ultra-violet light (254 nm) and ultra-violet light (365 nm) indicate that the
plate should be examined under an ultra-violet light having a maximum output at about
254 or at about 365 nm, as the case may be.
The term secondary spot means any spot other than the principal spot. Similarly, a
secondary band is any band other than the principal band.
Rf. Value
Measure and record the distance of each spot from the point of its application and
calculate the Rf. value by dividing the distance travelled by the spots by the distance
travelled by the front of the mobile phase.
4. SoP of Total Microbial Load
Microbial load test was conducted as per standards for Raw drugs and Finished Product
for organisms Fungi and Bacteria till one year for all samples.
OPERATING PROCEDURES
1) Weigh 10 grams/ ml of sample in the sterile safety cabinet.
2) Pour the sample into 100 ml soybean casein digest media.
3) Mix the sample properly to make it homogenous.
4) Incubate the sample at 37C for 24 hrs.
5) After 24 hrs of incubation test the sample for specific micro-organisms, that is,
Escheriachia coli, Salmonellaabony, Staphylococcus aureus, pseudomonas aeurginosa.
Methodology
TEST FOR ESCHERICHIA COLI
1) Pipette out 0.1ml of incubated sample into 10 ml of macConkey broth.
2) Incubate the sample at 37 C for 24 hrs.
3) Steak a loop full of sample on to a macConkey agar plate.
4) Incubate the plate at 370 C for 24 hrs.
5) Pink color colonies on the plate will give positive results.
CONFIRMATORY TEST
1) After incubation pipette out 0.1 ml of sample into 5ml peptone water.
2) Mix it well and keep it in incubator for 24 hrsat 37C.
3) After incubation put 0.5 ml Kovacs reagent to the tube from the side of the test tube.
4) If pink color ring appears on the surface of the sample the test is said to be positive.
TEST FOR SALMONELLA ABONY
1) Pipette out 0.1 ml of incubated sample into 10ml of selenite F broth.
2) Incubate the sample at 37 C for 24 hrs.
3) Steak a loop full of sample on to a Xylose lysine deoxycholate agar plate.
4) Incubate the plate at 37C for 24 hrs.
5) Black color colonies with metallic sheen on the plate will give positive results.
CONFIRMATORY TEST
1) After incubation subculture the sample on to a triple sugar iron agar.
2) First making a stab culture and then inoculating the surface.
3) Incubate the slant at 37 C for 24 hrs.
4) Acid and gas in the stab with or without blackening, absence of acidity from surface
growth together with absence of red color indicate the positive result.
Methodology
TEST FOR STAPHYLOCOCCUS AUREUS
1) Steak a loop full of sample on to a mannitol salt agar.
3) Pin point yellow color colonies on the plate will give positive results.
CONFIRMATORY TEST [COAGULASE TEST]
1) Transfer colony to rabbit plasma or horse plasma.
2) Incubate the tube into water bath at 500 C for 24 hrs.
3) Examine the tube every 3 hrs.
4) If coagulation occurs it indicates the positive results.
TEST FOR PSEUDOMONAS AERUGINOSA
1) Steak a loop full of sample on to a Cetrimide agar.
3) Greenish color colonies on the plate will give positive results.
CONFIRMATORY TEST
1) Transfer colony on each plate of pseudomonas agar for fluorescein and pseudomonas
agar for pyocyanine.
2) Incubate the tube into water bath at 500 C for 24 hrs.
3) After incubation observe the plate under UV light.
4) Check the fluorescence
Results
5. RESULTS
TABLE NO. 16 showing Physico-Chemical Analysis Of Both Raw Drug Sample
Parameters LoD % Total Ash AiA W.S.E. A.S.E
Haritaki (Ktm) 2.33% 3.26% 2.33% 68% 47.2%
API Limits NA NMT 5% NMT 5% NLT 60% NLT 40%
Haritaki (Bgm) 2.53% 3.16% 2.66% 63.2% 45.6%
Bibhitaki (Ktm) 2.66% 4.33% 0.66% 41.6% 15.2%
Bibhitaki (Bgm) 3% 4.16% 0.83% 39.2% 14.4%
Amalaki (Ktm) 3% 2.66% 1% 55.2% 52%
Amalaki (Bgm) 3.13% 3.33% 1.33% 52 49.6%

Results
Table No.17 Preliminary Phytochemical Screening Of Both Raw Drug Sample
a) Organic element (P= Present, A= Absent)
Haritaki Haritaki Bibhitaki Bibhitaki Amalaki Amalaki
( Ktm) ( Bgm) (Ktm) (Bgm) (Ktm) (Bgm)
W A W A W A W A W A W A
Carbohyd P P P P P P P P P P P P
rate
Reducing P P P P P P P P P P P P
sugar
Pentose A A A A A A A A A A A A
Sugar
Hexose A A A A A A A A A A A A
sugar
Protein P P P P P P P P P P P P
Amino P P P P P P P P P P P P
acid
Taninns P P P P P P P P P P P P
&
Phenolic
Comp.

Results
Steriods A A A A A A A A A A A A
Cardiac P P P P P P P P P P P P
Glycoside
Saponin P P P P P P P P P P P P
Glycoside
Flavonoid P P P P P P P P P P P P
Coumarin A A A A A A A A A A A A
Glycoside
Alkaloids P A P A P A P A P A P A
Monosacc P P P P P P P P P P P P
harides
Table No.18 Preliminary Phytochemical Screening
a) Inorganic elements (P= Present, A= Absent)
Haritaki Haritaki Bibhitak Bibhitaki Amalaki Amalaki
( Ktm) ( Bgm) i (Ktm) (Bgm) (Ktm) (Bgm)

Results
Calcium A A A A A A
Magnesium A A A A A A
Potassium A A A A A A
Sodium P P P P P P
Iron P P P P P P
Sulphate P P P P P P
Phosphate P P P P P P
Chloride P P P P P P
Carbonate P P P P P P
Nitrate A A A A A A
Table No. 19 showing Thin Layer Chromatography Of Both Raw Drugs:
Haritaki (Ktm) Haritaki (Bgm)
Normal Light : 0.05, 0.32 Normal Light : 0.03, 0.5
SW : 0.63, 0.65, 0.71, 0.75 SW : 0.05, 0.62, 0.68, 0.73, 0.8
LW : 0.45, 0.52, 0.63, 0.81 LW : 0.45, 0.6, 0.7, 0.92
Bibhitaki (Ktm) Bibhitaki (Bgm)
SW : 0.27, 0.35, 0.54, 0.65 SW : 0.3, 0.4, 0.52, 0.65
LW : 0.05, 0.35, 0.55, 0.62 LW : 0.07, 0.65, 0.68, 0.95

Results
Amalaki (Ktm) Amalaki (Bgm)
SW : 0.08, 0.15, 0.43, 0.58, 0.64 SW : 0.17, 0.25, 0.38, 0.5, 0.82
LW : 0.03, 0.26, 0.54, 0.6 LW : 0.13, 0.53, 0.72, 0.75
Table No. 20 Physico-Chemical Analysis Of Kathmandu Sealed:
Ktm. pH LoD % Total AiA WSA W.S.E. A.S.E Flow Bulk
Sealed Ash Rate Density
0 Mon. 4.41 4.66% 4.33% 0.66% 5.33% 51.2% 43.2% Fair 0.6
3 Mon. 4.05 2.66% 3.33% 0.33% 4.66% 52.8% 44% Good 0.58
6 Mon. 4.02 7.33% 4.33% 0.5% 5% 52% 44.8% Good 0.63
9 Mon. 4.25 3.33% 4% 1% 4% 56% 45.2% Good 0.63
12 Mon. 4.2 4% 3.9% 1.03% 4% 52% 44.16% Good 0.55
Table No. 21 Physico-Chemical Analysis Of Kathmandu Unsealed:

Results
Ktm. pH LoD Total AiA WSA W.S.E A.S.E Flo Bulk
UnSeale % Ash . w Densit
d Rate y
0 Mon. 4.4 4.66 4.33 0.66 5.33 51.2% 43.2% Fair 0.6
1 % % % %
3 Mon. 4.0 3.33 4.33 0.66 5% 51.2% 43.2% Goo 0.58
1 % % % d
6 Mon. 4.0 8% 5% 1% 5.33 50.72 44.32 Goo 0.61
4 % % % d
9 Mon. 4.3 4% 4.66 1.33 4.33 52% 44% Goo 0.59
4 % % % d
12 Mon. 4.3 3.66 4.5% 1.36 4.66 50.4% 42.4% Goo 0.56
% % % d
Table No. 22 Physico-Chemical Analysis Of Belgaum Sealed:
Bgm. pH LoD% Total AiA WSA W.S.E. A.S.E Flow Bulk
Sealed Ash Rate Density
0 Mon. 4.52 4% 5% 1% 5% 52% 42.4% Fair 0.56
3 Mon. 4.24 3.33% 4% 0.33% 5% 52% 44.8% Good 0.55
6 Mon. 4.22 6.66% 3.86% 0.33% 4.66% 52.4% 44% Good 0.55
9 Mon. 4.2 3.33% 3.33% 0.86% 3.66% 55.2% 44.96% Good 0.56
12 Mon. 4.21 3.66% 4.16% 0.9% 4% 52.48% 44% Good 0.55

Results
Table No. 23 Physico-Chemical Analysis Of Belgaum Unsealed
Bgm. pH LoD% Total AiA WSA W.S.E. A.S.E Flow Bulk
Unsealed Ash Rate Density
0 Mon. 4.52 4% 5% 1% 5% 52% 42.4% Fair 0.56
3 Mon. 4.38 4% 4.66% 1% 5.33% 50.4% 42.4% Good 0.56
6 Mon. 4.42 7.2% 4% 0.46% 4.83% 51.2% 42.4% Good 0.51
9 Mon. 4.39 4.66% 4.33% 1.06% 4.66% 52% 43.04% Good 0.56
12 Mon. 4.36 4.3% 4.66% 1.13% 4.33% 50.8% 42.8% Good 0.54
Table No. 26 Thin Layer Chromatography
KATHMANDU BELGAUM
Initial Normal Light : 0.31, 0.38 Normal Light : 0.37
Product SW : 0.06, 0.1, 0.15, 0.42, 0.55 SW : 0.03, 0.13, 0.3, 0.65, 0.82
LW : 0.75 LW : 0.7, 0.8
Sealed Unsealed Sealed Unsealed
Normal light : Normal light : Normal light : 0.42 Normal light : 0.4
3rd 0.33 0.28

Results
Month SW: 0.06, 0.11, SW: 0.06, 0.27, SW: 0.05,0.15, 0.47, SW: 0.06, 0.14, 0.28,
0.18, 0.42 0.6, 0.65 0.8 0.4
LW: 0.77 LW: 0.75 LW: 0.82 LW: 0.8
Normal light:0.34 Normal light :0.3 Normal light : 0.43 Normal light : 0.32
SW: 0.04, 0.09, SW: 0.06, 0.1, SW: 0.06, 0.13, 0.42, SW: 0.05, 0.08, 0.11,
0.17, 0.42, 0.6 0.28, 0.37, 0.6 0.81 0.63
6th LW: 0.74 LW: 0.75 LW: 0.82 LW: 0.77
Month
Normal light : Normal light : Normal light : 0.42 Normal light : Nil
9th 0.31 0.3
Month SW: 0.05, 0.11, SW: 0.06, 0.11, SW: 0.05, 0.13, 0.47, SW: 0.05, 0.08, 0.12,
0.42, 0.61, 0.77 0.4, 0.6, 0.65 0.8 0.57, 0.62
LW: 0.75 LW: 0.77 LW: 0.82 LW: 0.83
Normal light : Nil Normal light : Nil Normal light : Nil Normal light : Nil
SW: 0.03, 0.16, SW: 0.03, 0.07, SW: 0.06, 0.11, 0.18, SW: 0.03, 0.17, 0.25,
0.24, 0.4, O.46 0.15, 0.25 0.25 0.3
12th LW: 0.11, 0.3 LW: 0.062 LW: 0.06, 0.15 LW: 0.05
Month
Table no. 25 Preliminary Phytocochemical Screening Of Kathmandu Sample
a) Organic element (P= Present, A= Absent)

Results
Test Kathmandu Sealed Container Kathmandu Unsealed
Container
Initial 3 6 9 12 3 6 9 12
product
W A W A W A W A W A W A W A W A W A
Carbohydrate P P P P P P P P P P P P P P P P P P
Reducing A A A A A A A A A A A A A A A
sugar A A A
Pentose Sugar A A A A A A A A A A A A A A A A A A
Hexose sugar A A A A A A A A A A A A A A A A A A
Protein P P P P P P P P P P P P P P P P P P
Amino acid P P P P P P P P P P P P P P P P P P
Taninns & P P P P P P P P P P P P P P P P P P
Phenolic
Comp.
Steriods P P P P P P P P P P P P P P P P P P
Cardiac A A A A A A A A A A A A A A A A A A
Glycosides
Saponin A A A A A A A A A A A A A A A A A A

Results
Glycoside
Flavonoids P P P P P P P P P P P P P P P P P P
Coumarine A A A A A A A A A A A A A A A A A A
Glycosides
Alkaloids P P P P P P P P P P P P P P P P P P
Monosacchari P P P P P P P P P P P P P P P P P P
des
Table No.26 Preliminary Phytocochemical Screening Of Belgaum Sample
a) Organic elements (P= Present, A= Absent)
Test Belgaum Sealed Container Belgaum Unsealed Container
Initial 3 6 9 12 3 6 9 12
product
W A W A W A W A W A W A W A W A W A

Results
Carbohydrat P P P P P P P P P P P P P P P P P P
Reducing A A A A A A A A A A A A A A A A A A
sugar
Pentose A A A A A A A A A A A A A A A A A A
Sugar
Hexose sugar A A A A A A A A A A A A A A A A A A
Protein P P P P P P P P P P P P P P P P P P
Amino acid P P P P P P P P P P P P P P P P P P
Taninns & P P P P P P P P P P P P P P P P P P
Phenolic
Comp.
Steriods P P P P P P P P P P P P P P P P P P
Cardiac A A A A A A A A A A A A A A A A A A
Glycosides
Saponin A A A A A A A A A A A A A A A A A A
Glycoside
Flavonoids P P P P P P P P P P P P P P P P P P
Coumarine A A A A A A A A A A A A A A A A A A
Glycosides
Alkaloids P P P P P P P P P P P P P P P P P P

Results
Monosacchar P P P P P P P P P P P P P P P P P P
ides
Table no.27 Preliminary phytochemical screening of Kathmandu Samples
b) Inorganic elements (P= Present, A= Absent)
Test Kathmandu Sealed Container Kathmandu Unsealed
Container
Initial 3 6 9 12 3 6 9 12
product
Calcium A A A A A A A A A
Magnesium A A A A A A A A A
Potassium A A A A A A A A A
Sodium P P P P P P P P P
Iron P P P P P P P P P
Sulphate P P P A A A A A A
Phosphate P P P P P P P P P
Chloride P P P P P P P P P
Carbonate A A A A A A A A A
Nitrate P P P P P P P P P

Results
Table no.28 Preliminary phytochemical screening of Belagavi Samples
b) Inorganic elements (P= Present, A= Absent)
Test Belgaum Sealed Container Belgaum Unsealed Container
Initial 3 6 9 12 3 6 9 12
product
Calcium A A A A A A A A A
Magnesium A A A A A A A A A
Potassium A A A A A A A A A
Sodium P P P P P P P P P
Iron P P P P P P P P P
Sulphate P P P A A P P A A
Phosphate P P P P P P P P P
Chloride P P P P P P P P P
Carbonate A A A A A A A A A
Nitrate P P P P P P P P P

Results
Table no. 29 showing Test for Total Alkaloids
Initial product: Ktm-3.49% Bgm- 3.28%
Period Kathmandu Belgaum
Sealed container Unsealed Sealed container Unsealed
3 month 3.15 % 2.95% 3.87% 3.51%
6 month 2.12 % 1.98% 2.22% 2.01%
9 month 2.64% 2.45% 2.01 % 2.64%
12 month 2.68% 2.15% 2.79% 2.14%
Table no. 30 showing Test for Total Tannin
Initial product: Ktm-35.32% Bgm- 37.55%
Period Kathmandu Belgavi
Sealed container Unsealed Sealed container Unsealed
3 month 42.76% 40.81% 40.83% 38.48%
6 month 29.18% 28.01% 31.25% 30.35%
9 month 31.25% 29.45% 35.55% 32.35%
12 month 41.22% 24.35% 38.10% 24.35%

Results
Table No.31 showing Total Microbial Load (TML)
Month 0 Month 3 Month 6 Month 9 Month 12 Month
Sample
(MLT) Under Limit Under Limit Under Limit Under Limit Under Limit
Under Limit Under Limit Fungal Under Limit Under Limit

Ktm.Sealed
Growth
(TML)
TNTC

Ktm.Unsealed
Growth
(TML)
TNTC

Bgm.Sealed
Growth
(TML)
TNTC

Bgm. Unsealed
Growth
(TML)
TNTC

Discussion
6. DISCUSSION
Analytical part
Raw materials
All the raw drugs analysis was done in central research facility and value of
this drug was under API limit.
Microbial study of raw drugs:
Total microbial load & Microbial limit test: Value was under limit of all
individual drugs as per the IP.
Triphala Churna
1. Organoleptic characters: There was no changes observed in organoleptic
Characters (Form, Odour, Colour & Taste) of churna of all sample with both
conditions. This may indicate Churna was physically stable for the period of 12
months.
2. LOD: There was slightly difference in LoD of 6 month of all samples due to
Temperature & Humidity changes in Rainy Season (August).
3. Ash value/ Acid insoluble ash: Minimal variations were observed in initial
sample between end point or upto 12th month.

Discussion
4. Water soluble extract/ Alcohol soluble extract, Bulk density, True density, pH
value, Angle of repose, Flow rate-
There was no much variation in these parameters from fresh product to 12 months.
5. Preliminary physico chemical screening:
a. Preliminary physico-chemical screening indicated presence of inorganic
compounds Sodium, Iron, Phosphate, Chloride, Nitrate & Sulphate was present till 6
months of all samples but Sulphate was absent in 9 month & 12 months all samples
may be due to absence of Sulphate in Ash.
b. Preliminary phto-chemical screening indicated presence of inorganic
compounds Carbohydrate, Proteins, Amino Acids, Tannins & Phenolic Compounds,
Steroids, Alkaloids, Flavonoids & Monosaccharaides was present in all samples till
one year.
2. Microbial study:
a. Total microbial load:
In both samples (Triphala Churna of Kathmandu & Belgaum) Total Bacterial
Count (TBC) were within limits but in Total Fungal Count (TFC) at six month
in all samples it was TNTC.
It was due to highly hygroscopic nature of the sample powders, and effect of
Moisture , much variance in Temperature & Humidity in comparison to other

o o
Month. (Season- August 2015- Temperature = 23.9 C+ 3.56 C & Humidity =
64 - 72 %)

Discussion
b. Microbial limit test:
In both samples, MLT results were within limit.
3. Quantitative analysis screening:
Total Alkaloids & Total Tannins : Total alkaloids percentage values was seen few
variations due to variance in tempaerature & Humidity and also hygroscopic of
nature of churna.
3. Stability study:
In TLC Rf. values of all sample 0 to 12th month showed negligible variation
this means extractive value was not more difference i.e. the stability in
qualitative perspective was not more differ.
As Triphala Churna was prepared from two different geographical sources
(Climatic Zone 2- Kathmandu ,NEPAL & Climatic Zone 3- Belagavi,
INDIA), but also Kathmandu Samples (from Climatic Zone 2) were Stable
in Climatic Zone 3 also.

Scope for further Study
7. SCOPE FOR FURTHER STUDY
Stability study of Triphala Churna (other Churnas also)
prepared from two Geographical sources along with single
ingredients kept in Sealed & Unsealed Container at Room
Temperature & Stability Chamber with HPTLC & Aflatoxins.

Conclusion
8 .CONCLUSION
Organoleptic characters of all samples of Triphala Churna were similar for the
period of 12 months.
Minimum variations were observed in physico chemical analysis and
microbial load , extractive values, Rf values in all samples of both conditions
compared to initial product for the period of 12 months.
Kathmandu & Belgaum Sealed sample showed more stable in the difference of
Percentage of Tannins & Alkaloid.
Summary
9.SUMMARY
Churna kalpana is one of the important dosage of Bhaishajya kalpana, hence
stability study of Churna was selected in present study.
Triphala Churna is used 90%in Ayurvedic medicine either directly as
medicine or for the preparation of other Ayurvedic preparations like Ghrita,
Vati etc. It is prepared by combination of dried fruit pulps of Haritaki
(Terminalia chebula Retz.), Bibhitaka (Terminalia bellirica (Gaertn.) Roxb.)
and Amalaki (Emblica officinalis Gaertn.).
Raw drugs were collected from two geographical sources, cleaned dried &
powdered, passed through 80 mesh sieve & mixed together in equal ration to
prepare Triphala Churna.
The formulation was studied by following parameters-
Physicochemical analysis which involves ash values, acid insoluble ash, water
soluble ash, extractive values etc.
All the parameters mentioned under Physicochemical analysis was done by
following proper Standard Operative Procedure (SOP)
Stability of the formulation was determined physico chemically after 12
months of both samples.
Kathmandu & Belgaum Sealed samples were more stable at room temperature
in Percentage of Tannins & Alkaloid.

Bibliography
10.BIBLIOGRAPHY
1. www.ich.org/guidelines/stability-testing-photostabilility-testing
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Dissertation, 2015 kleus bmk Ayurved Mahavidyalaya, Shahpur, Belgaum,
KARNATAKA

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Photoplates
Preparation of Individual Preparation of Triphala Churna

churna by pulverizer
Fumigation Labelling & Packaging of

Final Products
Photoplates
Different Analytical Procedure

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STABILITY STUDY OF TRIPHALA CHURNA PREPARED

FROM TWO GEOGRAPHICAL SOURCES KEPT IN SEALED

In partial fulfillment of the requirements for the degree of

M.D (AYURVEDA VACHASPATI)

Dr. PRASHANT KUMAR SINGH B.A.M.S.

(Registration No: KB0113004)

Under the Guidance of

Dr. R. R. HIREMATH M.D (Ayu), Ph.D

Mr. AJIT C. LINGAYAT M.Sc(Medicinal Plant)

DEPARTMENT OF RASASHASTRA & BHAISHAJYA KALPANA

KLE University Shri B M Kankanawadi Ayurved Mahavidyalaya,

I, Dr. PRASHANT KUMAR SINGH hereby declare that the

I am aware of definition of plagiarism as detailed below:

An act or instance of using or closely imitating the language and

I hereby declare that the dissertation prepared by me is original-

Date: Signature of the Research Scholar

(KLE DEEMED UNIVERSITY)

(Re-Accredited A Grade by NAAC)

[Placed in Category A by MHRD (GoI)]

We hereby declare that KLE ACADEMY OF HIGHER EDUCATION

AND RESEARCH, BELAGAVI, KARNATAKA shall have the rights

to preserve, use and disseminate this dissertation in print or electronic

format for academic/research purpose.

KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH,

(KLE DEEMED UNIVERSITY)

(Re-Accredited A Grade by NAAC)

[Placed in Category A by MHRD (GoI)]

I hereby declare that the dissertation entitled STABILITY STUDY

OF TRIPHALA CHURNA PREPARED FROM TWO

Place: Belagavi Signature

(KLE DEEMED UNIVERSITY)

(Re-Accredited A Grade by NAAC)

[Placed in Category A by MHRD (GoI)]

This is to certify that the dissertation entitled STABILITY

STUDY OF TRIPHALA CHURNA PREPARED FROM TWO

GEOGRAPHICAL SOURCES KEPT IN SEALED &

UNSEALED CONTAINER AT ROOM TEMPERATURE is a

bonafide record of original research carried out by Dr. PRASHANT

KUMAR SINGH for the partial fulfillment of the requirement for

degree of M.D(Ayurveda Vachaspati) in RASASHASTRA

AND BHAISHAJYA KALPANA under my supervision.

Place: Belagavi Signature

Date: Name & Address of Guide

(Re-Accredited A Grade by NAAC)

ENDORSEMENT BY THE HOD & PRINCIPAL OF THE

This is to certify that this dissertation entitled STABILITY

Dr. R.S.HIREMATH M.D (Ayu) Ph.D Dr B.S.PRASAD M.D (Ayu), Ph.D

in every moment of my study, which made this work successful.

In this unforgettable moment of successful completion of the dissertation work, it

is with deep sense of gratitude. I bow to Almighty, My parents and ShriBasappanna.

Mallappanna.Kankanawadi, who blessed me to achieve this milestone.

I extend my sincere thanks to my guide Dr. R.R.HIREMATH M.D (Ayu), PhD

Reader KLEUs Shri B.M.K Ayurveda Mahavidyalaya, Shahapur,Belagavi for the

magnitude of her Guidance, encouragement, support and helpful suggestions throughout

the study which literally helped me to conduct my work successfully.

Shahapur,Belagavi who has encouraged and guided me in all aspects.

I express my deep sense of gratitude to my Co-Guide Mr. AJIT C.

Ayurveda Mahavidyalaya, Shahapur,Belagavi;for his nonenervative timely guidance.

My sincere thanks to Dr. R.S. HIREMATH, HoD, Dept. of Rasashastra &

I express my deep sense of gratitude to Dr. Giridhar Vedantam.Prof,

I would like to express my immense thanks to my teachers Dr. P.G.JADAR,

S.A.DODDAMANI for their timely opinions & co-operation during my dissertation

I wish to express my gratitude to Dr. M.B.GUNDKALLE, MR.