Pyrimethamine Tablets
» Pyrimethamine Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of pyrimethamine (C12H13ClN4).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
A: The UV absorption spectrum of the Assay Preparation exhibits maxima at the same wavelengths as that of a similar solution of USP Pyrimethamine RS.
B: To a quantity of powdered Tablets, equivalent to about 250 mg of pyrimethamine, add 25 mL of acetone, boil for 2 minutes, and filter through a sintered-glass crucible. Repeat this treatment three times with 25-mL portions of acetone. Evaporate the combined filtrates carefully on a steam bath with the aid of a current of air to dryness: the residue responds to Identification test A under Pyrimethamine, and melts between 237 and 242 (see Melting Range or Temperature 741).
Dissolution 711
Medium: 0.1 N hydrochloric acid; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C12H13ClN4 dissolved by employing UV absorption at the wavelength of maximum absorbance at about 273 nm on filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Pyrimethamine RS in the same Medium.
Tolerances— Not less than 75% (Q) of the labeled amount of C12H13ClN4 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Procedure for content uniformity— Transfer 1 Tablet to a 100-mL volumetric flask, add 25 mL of 0.1 N hydrochloric acid, warm the flask on a steam bath for 5 minutes, cool, dilute with 0.1 N hydrochloric acid to volume, mix, and filter, rejecting the first few mL of the filtrate. Pipet a portion of the clear filtrate, equivalent to about 2.5 mg of pyrimethamine, into a 250-mL volumetric flask, dilute with 0.1 N hydrochloric acid to volume, and mix. Dissolve an accurately weighed quantity of USP Pyrimethamine RS in 0.1 N hydrochloric acid, and dilute quantitatively and stepwise with 0.1 N hydrochloric acid to obtain a Standard solution having a known concentration of about 10 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 273 nm, with a suitable spectrophotometer, using 0.1 N hydrochloric acid as the blank. Calculate the quantity, in mg, of C12H13ClN4 in the Tablet taken by the formula:
(T/D)C(AU / AS)
in which T is the labeled quantity, in mg, of pyrimethamine in the Tablet; D is the concentration, in µg per mL, of pyrimethamine in the solution from the Tablet, on the basis of the labeled quantity per Tablet and the extent of dilution; C is the concentration, in µg per mL, of USP Pyrimethamine RS in the Standard solution; and AU and AS are the absorbances of the solution from the Tablet and the Standard solution, respectively.
Assay— Proceed with Tablets as directed under Salts of Organic Nitrogenous Bases 501, diluting 5.0 mL each of the Standard Preparation and the Assay Preparation, respectively, with 0.5 N sulfuric acid to 200.0 mL and determining the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 273 nm. Calculate the quantity, in mg, of pyrimethamine (C12H13ClN4) in the portion of Tablets taken by the formula:
50C(AU / AS)
in which C is the concentration, in mg per mL, of USP Pyrimethamine RS in the Standard Preparation; and AU and AS are as defined in the chapter.
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Topic/Question Contact Expert Committee
Monograph Behnam Davani, Ph.D., M.B.A.
Senior Scientist
1-301-816-8394
(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3454
Pharmacopeial Forum: Volume No. 30(3) Page 929