Triprolidine and Pseudoephedrine Hydrochlorides Tablets
» Triprolidine and Pseudoephedrine Hydrochlorides Tablets contain not less than 90.0 percent and not more than 110.0 percent 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 11
A: The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those of the Standard preparation as obtained in the Assay.
B: Transfer 1 Tablet to a suitable glass-stoppered tube, add 10 mL of water, shake for 5 minutes, and allow the solids to settle. Prepare a Standard solution in water of USP Pseudoephedrine Hydrochloride RS and USP Triprolidine Hydrochloride RS having known concentrations of 6 mg per mL and 250 µg per mL, respectively. Separately apply 10-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography 621) 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 UV light: the RF values of the principal spots obtained from the test solution correspond to those obtained from the Standard solution.
Dissolution, Procedure for a Pooled Sample 711
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Determine the amounts of pseudoephedrine hydrochloride and triprolidine hydrochloride dissolved using the following method.
Mobile phase and Chromatographic system Proceed as directed in the Assay under Triprolidine and Pseudoephedrine Hydrochlorides Oral Solution.
Procedure Inject an accurately measured volume (about 200 µL) 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 RS and USP Triprolidine Hydrochloride RS in the same medium and similarly chromatographed.
Tolerances Not less than 75% (Q) of the labeled amounts of C10H15NO·HCl and C19H22N2·HCl·H2O is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements for Content Uniformity with respect to triprolidine hydrochloride and to pseudoephedrine hydrochloride.
Mobile phase and Standard preparation Prepare as directed in the Assay under Triprolidine and Pseudoephedrine Hydrochlorides Oral Solution.
Assay preparation Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 120 mg of pseudoephedrine hydrochloride, to a 100-mL volumetric flask. Add about 10 mL of 0.01 N hydrochloric acid, and sonicate for 10 minutes. Cool to room temperature. Dilute with 0.01 N hydrochloric acid to volume, mix, and filter.
Chromatographic system (see Chromatography 621) and Procedure Proceed as directed in the Assay under Triprolidine and Pseudoephedrine Hydrochlorides Oral Solution, 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 which C is the concentration, in mg per mL, of USP Pseudoephedrine Hydrochloride RS in the Standard preparation; and rU and rS are the peak responses for pseudoephedrine hydrochloride obtained from the Assay preparation and the Standard 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 332.88 and 314.86 are the molecular weights of triprolidine hydrochloride monohydrate and anhydrous triprolidine hydrochloride, respectively; C is the concentration, in mg per mL, calculated on the anhydrous basis, of USP Triprolidine Hydrochloride RS in the Standard preparation; and rU and rS are the peak responses for triprolidine hydrochloride obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4962Pharmacopeial Forum: Volume No. 30(1) Page 192