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Trimethoprim and Sulfamethoxazole Tablets

Action and use


Dihydrofolate reductase inhibitor + sulfonamide antibacterial.

DEFINITION
Co-trimoxazole Tablets contain Trimethoprim and Sulfamethoxazole in the
proportions, by weight, 1 part to 5 parts.
The tablets comply with the requirements stated under Tablets and with the
following requirements.

Content of trimethoprim, C14H18N4O3


92.5 to 107.5% of the stated amount of trimethoprim.

Content of sulfamethoxazole, C10H11N3O3S


92.5 to 107.5% of the stated amount of sulfamethoxazole.

IDENTIFICATION
A. Filter the aqueous layer reserved in the Assay for trimethoprim. Add, drop
wise, sufficient 2M hydrochloric acid to the filtrate to make it just acidic and
extract with 50 mL of ether . Wash the ether layer with 10 mL of water, shake with
5 g of anhydrous sodium sulfate, filter and evaporate the filtrate to dryness using a
rotary evaporator. Dissolve the residue in the minimum volume of a 5% w/v
solution of sodium carbonate, add 1M hydrochloric acid drop wise until
precipitation is complete and filter. Wash the residue sparingly with water and dry
at 105. The infrared absorption spectrum of the residue, Appendix II A, is
concordant with the reference spectrum of sulfamethoxazole (RS 327).
B. To a quantity of the powdered tablets containing 50 mg of Trimethoprim add
30 mL of 0.1M sodium hydroxide and extract with two 50 mL quantities of
chloroform. Wash the combined chloroform extracts with two 10-mL quantities of
0.1M sodium hydroxide and then with 10 mL of water. Shake with 5 g of anhydrous
sodium sulfate, filter and evaporate to dryness using a rotary evaporator. The

infrared absorption spectrum of the residue, Appendix II A, is concordant with the


reference spectrum of trimethoprim (RS 354)
C. Carry out the method for thin-layer chromatography, Appendix III A, using the
following solutions.
(1) Shake a quantity of the powdered tablets containing 0.4 g of Sulfamethoxazole
with 20 mL of methanol and filter.
(2) 2.0% w/v of sulfamethoxazole BPCRS in methanol .
(3) 0.4% w/v of trimethoprim BPCRS in methanol

CHROMATOGRAPHIC CONDITIONS
(a) Use as the coating silica gel G.
(b) Use the mobile phase as described below.
(c) Apply 5 L of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air and spray with dilute potassium
iodobismuthate solution.

MOBILE PHASE
5 volumes of dimethylformamide, 10 volumes of methanol and 100 volumes of
chloroform.

CONFIRMATION
One of the principal spots in the chromatogram obtained with solution (1)
corresponds to the spot in the chromatogram obtained with solution (2) and the
other corresponds to the spot in the chromatogram obtained with solution (3).

ASSAY
Weigh and powder 20 tablets.

For trimethoprim

To a quantity of the powder containing 50 mg of Trimethoprim add 30 mL of 0.1M


sodium hydroxide and extract with four 50-mL quantities of chloroform, washing
each extract with the same two 10-mL quantities of 0.1M sodium hydroxide.
Reserve the aqueous layer for test A for Identification. Combine the chloroform
extracts and extract with four 50-mL quantities of 1M acetic acid . Wash the
combined extracts with 5 mL of chloroform and dilute the aqueous extracts to 250
mL with 1M acetic acid . To 10 mL of the solution add 10 mL of 1M acetic acid and
sufficient water to produce 100 mL and measure the absorbance of the resulting
solution at the maximum at 271 nm, Appendix II B. Calculate the content of
C14H18N4O3 taking 204 as the value of A(1%, 1 cm) at the maximum at 271 nm.

For sulfamethoxazole

Dissolve, as completely as possible, a quantity of the powder containing 0.5 g of


Sulfamethoxazole in 60 mL of water and 10 mL of hydrochloric acid . Add 3 g of
potassium bromide, cool in ice and titrate slowly with 0.1M sodium nitrite VS,
stirring constantly and determining the end point electrometrically. Each mL of
0.1M sodium nitrite VS is equivalent to 25.33 mg of C10H11N3O3S.