Triprolidine and Pseudoephedrine Hydrochlorides Tablets »Triprolidine and Pseudoephedrine Hydrochlorides Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amounts of triprolidine hydrochloride (C19H22N2·HCl·H2O)and pseudoephedrine hydrochloride (C10H15NO·HCl). Packaging and storage— Preserve in tight,light-resistant containers. USP Reference standards á11ñ USP Triprolidine Hydrochloride RS.USP Pseudoephedrine Hydrochloride RS. Identification— A: The retention times of the major peaks in the chromatogram of theAssay preparation correspond to those of theStandard preparation as obtained in theAssay. B: Transfer 1Tablet to a suitable glass-stoppered tube,add 10mLof water,shake for 5minutes,and allow the solids to settle.Prepare a Standard solution in water of USP Pseudoephedrine Hydrochloride RSand USP Triprolidine Hydrochloride RShaving known concentrations of 6mg per mLand 250µg per mL,respectively.Separately apply 10-µLportions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (seeChromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and develop the chromatogram in a solvent system consisting of a mixture of butyl alcohol,glacial acetic acid,and water (8:2:2)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate,mark the solvent front,allow the solvent to evaporate,and examine the plate under short-and long-wavelength UVlight:theRFvalues of the principal spots obtained from the test solution correspond to those obtained from the Standard solution. Dissolution,Procedure for a Pooled Sample á711ñ Medium: water;900mL. Apparatus 2: 50rpm. Time: 45minutes. Determine the amounts of pseudoephedrine hydrochloride and triprolidine hydrochloride dissolved using the following method. Mobile phaseand Chromatographic system— Proceed as directed in theAssay underTriprolidine and Pseudoephedrine Hydrochlorides Syrup (Oral Solution,Official June 1,2005). Procedure— Inject an accurately measured volume (about 200µL)of a filtered portion of the solution under test into the chromatograph by means of a microsyringe or a sampling valve,record the chromatogram,and measure the responses for the major peaks.Calculate the quantities of pseudoephedrine hydrochloride (C10H15NO·HCl)and triprolidine hydrochloride (C19H22N2·HCl·H2O)dissolved in comparison with a Standard solution having known concentrations of USP Pseudoephedrine Hydrochloride RSand USP Triprolidine Hydrochloride RSin the same medium and similarly chromatographed. Tolerances— Not less than 75%(Q)of the labeled amounts of C10H15NO·HCl and C19H22N2·HCl·H2Ois dissolved in 45minutes. Uniformity of dosage units á905ñ: meet the requirements for Content Uniformitywith respect to triprolidine hydrochloride and to pseudoephedrine hydrochloride. Assay— Mobile phaseand Standard preparation— Prepare as directed in theAssay underTriprolidine and Pseudoephedrine Hydrochlorides Syrup (Oral Solution,Official June 1,2005) Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 120mg of pseudoephedrine hydrochloride,to a 100-mLvolumetric flask.Add about 10mLof 0.01Nhydrochloric acid,and sonicate for 10minutes.Cool to room temperature.Dilute with 0.01Nhydrochloric acid to volume,mix,and filter. Chromatographic system(see Chromatography á621ñ)and Procedure— Proceed as directed in theAssay underTriprolidine and Pseudoephedrine Hydrochlorides Syrup (Oral Solution,Official June 1,2005)except to calculate the quantity,in mg,of pseudoephedrine hydrochloride (C10H15NO·HCl)in the portion of Tablets taken by the formula: 100C(rU/rS), in whichCis the concentration,in mg per mL,of USP Pseudoephedrine Hydrochloride RSin theStandard preparation;andrUandrSare the peak responses for pseudoephedrine hydrochloride obtained from theAssay preparation and theStandard preparation,respectively.Calculate the quantity,in mg,of triprolidine hydrochloride (C19H22N2·HCl·H2O)in the portion of Tablets taken by the formula: (332.88/314.86)(100C)(rU/rS), in which 332.88and 314.86are the molecular weights of triprolidine hydrochloride monohydrate and anhydrous triprolidine hydrochloride,respectively;Cis the concentration,in mg per mL,calculated on the anhydrous basis,of USP Triprolidine Hydrochloride RSin theStandard preparation;andrUandrSare the peak responses for triprolidine hydrochloride obtained from theAssay preparation and theStandard preparation,respectively. Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist Expert Committee:(PA1)Pharmaceutical Analysis 1 USP28–NF23Page 1994 Pharmacopeial Forum:Volume No.30(1)Page 192 Phone Number:1-301-816-8379