Papaverine Hydrochloride Tablets
»Papaverine Hydrochloride Tablets contain not less than 93.0percent and not more than 107.0percent of the labeled amount of C20H21NO4·HCl.
Packaging and storage— Preserve in tight containers.
Identification— Add a portion of powdered Tablets,equivalent to about 30mg of papaverine hydrochloride,to 10mLof 0.1Nhydrochloric acid in a separator.Extract the mixture with 10mLof chloroform,filter the chloroform phase through paper,evaporate the solvent on a steam bath,and dry the residue at 105for 2hours:it responds to Identificationtest Aunder Papaverine Hydrochloride.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 30minutes.
Procedure— Determine the amount of C20H21NO4·HCl dissolved from UVabsorbances at the wavelength of maximum absorbance at about 250nm on filtered portions of the solution under test,suitably diluted with 0.1Nhydrochloric acid,in comparison with a Standard solution having a known concentration of USP Papaverine Hydrochloride RSin the same Medium.
Tolerances— Not less than 80%(Q)of the labeled amount of C20H21NO4·HCl is dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— Transfer 1finely powdered Tablet to a 250-mLvolumetric flask,add 50mLof water and 3mLof hydrochloric acid,mix,and allow to stand for 15minutes with occasional agitation.Dilute with water to volume,mix,and filter,discarding the first 20mLof the filtrate.Dilute a portion of the subsequent filtrate quantitatively and stepwise,if necessary,with water to provide a solution containing approximately 2.4µg 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 2.4µg per mL,in 1-cm cells,at the wavelength of maximum absorbance at about 250nm,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 Tis the labeled quantity,in mg,of papaverine hydrochloride in the Tablet;Cis the concentration,in µg per mL,of USP Papaverine Hydrochloride RSin the Standard solution;Dis 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 AUand ASare the absorbances of the solution from the Tablet and the Standard solution,respectively.
Assay— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 30mg of papaverine hydrochloride,to a glass-stoppered conical flask,add about 100mLof 0.1Nhydrochloric acid,and shake by mechanical means for 15minutes.Filter the mixture into a 200-mLvolumetric flask,and add 0.1Nhydrochloric acid to volume.Proceed as directed in the Assayunder Papaverine Hydrochloride Injection,beginning with “Pipet 3mLof 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 Cis the concentration,in µg per mL,of USP Papaverine Hydrochloride RSin the Standard solution,and AUand ASare 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:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1466
Phone Number:1-301-816-8305