Phenazopyridine Hydrochloride Tablets

» Phenazopyridine Hydrochloride Tablets contain not less than 90.0 percent and not more
than 110.0 percent of the labeled amount of phenazopyridine hydrochloride
(C11H11N5·HCl).

Packaging and storage— Preserve in tight containers.

USP Reference standards 11 —

USP Phenazopyridine Hydrochloride RS.

Identification— Transfer a quantity of finely ground Tablets, equivalent to about 50 mg of

phenazopyridine hydrochloride, to a 125-mL separator, add 50 mL of water, 1 mL of 1 N hydrochloric
acid, and 5 mL of a saturated sodium chloride solution, and shake to dissolve. Extract with two 25-mL
portions of chloroform, and discard the chloroform. Add 5 mL of 1 N sodium hydroxide to the aqueous
solution, and extract with one 50-mL portion of chloroform. Transfer the chloroform layer to a second
125-mL separator, and wash with one 50-mL portion of 0.1 N sodium hydroxide. Filter the chloroform
layer through a pledget of cotton previously washed with chloroform. Add 5 drops of hydrochloric acid
to the filtrate, and evaporate under a current of air on a steam bath to dryness. Add 5 mL of alcohol,
and evaporate. Dry the residue at 105 for 4 hours: the IR absorption spectrum of a potassium
bromide dispersion of the dried residue so obtained exhibits maxima only at the same wavelengths as
that of a similar preparation of USP Phenazopyridine Hydrochloride RS.

Dissolution 711 —
Medium: water; 900 mL.

Apparatus 2: 50 rpm.

Time: 45 minutes.
Procedure— Determine the amount of C11H11N5·HCl dissolved from UV absorbances at the
wavelength of maximum absorbance at about 422 nm on filtered portions of the solution under test,
suitably diluted with Dissolution Medium in comparison with a Standard solution having a known
concentration of USP Phenazopyridine Hydrochloride RS in the same Medium.
Tolerances— Not less than 75% (Q) of the labeled amount of C11H11N5.HCl is dissolved in 45
minutes.

Uniformity of dosage units 905 : meet the requirements.

Assay—

Phosphate buffer— Dissolve 2.64 g of dibasic ammonium phosphate in about 900 mL of water. Adjust
with phosphoric acid to a pH of 3.0, dilute with water to 1000 mL, and mix.

Mobile phase— Prepare a mixture of Phosphate buffer and methanol (50:50). Make adjustments if
necessary (see System Suitability under Chromatography 621 ).
Standard preparation— Transfer about 50 mg of USP Phenazopyridine Hydrochloride RS, accurately
weighed, to a 100-mL volumetric flask. Add 50 mL of methanol, and swirl to dissolve. Dilute with
Phosphate buffer to volume, mix, and pass through a filter having a 0.5-µm or finer porosity.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately
weighed portion of the powder, equivalent to about 100 mg of phenazopyridine hydrochloride, to a
200-mL volumetric flask. Add 100 mL of methanol, and sonicate for 10 minutes. Add about 75 mL of
Phosphate buffer, and sonicate for an additional 10 minutes, with occasional mixing. Dilute with
Phosphate buffer to volume, and mix. Pass this solution through a filter having a 0.5-µm or finer
porosity.

Chromatographic system (see Chromatography 621 )— The liquid chromatograph is equipped with
a 220-nm detector and a 3.9-mm × 30-cm column that contains packing L1. The flow rate is about 1.5
mL per minute. Chromatograph the Standard preparation, and record the responses as directed for
Procedure: the column efficiency is not less than 1400 theoretical plates; the tailing factor for the
analyte peak is not more than 2.0; and the relative standard deviation for replicate injections is not
more than 2.0%.

Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the responses
for the major peaks. Calculate the quantity, in mg, of C11H11N5. HCl in the portion of Tablets taken by
the formula:
200C(rU / rS)
in which C is the concentration, in mg per mL, of USP Phenazopyridine Hydrochloride RS in the
Standard preparation; and rU and rS are the phenazopyridine peak responses obtained from the Assay
preparation and the Standard preparation, respectively.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D. (MDCCA05) Monograph Development-Cough
Scientist Cold and Analgesics
1-301-816-8139
Reference Lili Wang, Technical Services
Standards Scientist
1-301-816-8129
RSTech@usp.org
711 Margareth R.C. Marques, (BPC05) Biopharmaceutics05
Ph.D.
Senior Scientist
1-301-816-8106
USP32–NF27 Page 3265