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Papaverine Hydrochloride Tablets
» Papaverine Hydrochloride Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of C20H21NO4·HCl.
Packaging and storage— Preserve in tight containers.
Identification— Add a portion of powdered Tablets, equivalent to about 30 mg of papaverine hydrochloride, to 10 mL of 0.1 N hydrochloric acid in a separator. Extract the mixture with 10 mL of chloroform, filter the chloroform phase through paper, evaporate the solvent on a steam bath, and dry the residue at 105 for 2 hours: it responds to Identification test A under Papaverine Hydrochloride.
Dissolution 711—
Medium: water; 900 mL.
Apparatus 1: 100 rpm.
Time: 30 minutes.
Procedure— Determine the amount of C20H21NO4·HCl dissolved from UV absorbances at the wavelength of maximum absorbance at about 250 nm on filtered portions of the solution under test, suitably diluted with 0.1 N hydrochloric acid, in comparison with a Standard solution having a known concentration of USP Papaverine Hydrochloride RS in the same Medium.
Tolerances— Not less than 80% (Q) of the labeled amount of C20H21NO4·HCl is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Procedure for content uniformity— Transfer 1 finely powdered Tablet to a 250-mL volumetric flask, add 50 mL of water and 3 mL of hydrochloric acid, mix, and allow to stand for 15 minutes with occasional agitation. Dilute with water to volume, mix, and filter, discarding the first 20 mL of the filtrate. Dilute a portion of the subsequent filtrate quantitatively and stepwise, if necessary, with water to provide a solution containing approximately 2.4 µg of papaverine hydrochloride per mL. Concomitantly determine the absorbances of this solution and a solution of USP Papaverine Hydrochloride RS, in the same medium at a concentration of about 2.4 µg per mL, in 1-cm cells, at the wavelength of maximum absorbance at about 250 nm, with a suitable spectrophotometer, using water as the blank. Calculate the quantity, in mg, of C20H21NO4·HCl in the Tablet by the formula:
(TC / D)(AU / AS),
in which T is the labeled quantity, in mg, of papaverine hydrochloride in the Tablet; C is the concentration, in µg per mL, of USP Papaverine Hydrochloride RS in the Standard solution; D is the concentration, in µg per mL, of the solution from the Tablet based upon the labeled quantity per Tablet and the extent of dilution; and AU and AS are the absorbances of the solution from the Tablet and the Standard solution, respectively.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 30 mg of papaverine hydrochloride, to a glass-stoppered conical flask, add about 100 mL of 0.1 N hydrochloric acid, and shake by mechanical means for 15 minutes. Filter the mixture into a 200-mL volumetric flask, and add 0.1 N hydrochloric acid to volume. Proceed as directed in the Assay under Papaverine Hydrochloride Injection, beginning with “Pipet 3 mL of this solution into a separator.” Calculate the quantity, in mg, of C20H21NO4·HCl in the portion of Tablets taken by the formula:
6.67C(AU / AS),
in which C is the concentration, in µg per mL, of USP Papaverine Hydrochloride RS in the Standard solution, and AU and AS are the absorbances of the solution from the Tablets and the Standard solution, respectively.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (MDCV05) Monograph Development-Cardiovascular
USP29–NF24 Page 1636
Phone Number : 1-301-816-8305