Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF DEXTROMETHORPHAN HBR AND TRIPROLIDINE

Sonu Soni*, Kashyap Thummar, Janki Goswami and Foram Ravat

.

Abstract

High-performance liquid chromatographic (HPLC) and UV spectrophotometric methods were developed and validated for the quantitative determination of Dextromethorphan HBr and Triprolidine. A simple, rapid, sensitive, accurate, precise isocratic elution mode analytical method was developed and validated for the simultaneous estimation of Dextromethorphan HBr and Triprolidine. Hypersil BDS C18 (250 mm × 4.6 mm, 5 μm) was used as a stationary phase. The mobile phase used was [MeOH: Phosphate Buffer (35:65)] pH 4 adjusted using 1% orthophosphoric acid at the flow rate of 1 mL/min, Injection volume was 20 μL and the UV detector 2000 was used at 240 nm with methanol as diluent. The linearity of the Proposed method was investigated in the range of 80-120μg/ml (r2 = 0.999) for Dextromethorphan HBr and 5-15μg/ml (R2 = 0.999) for Triprolidine. The % Accuracy was found to be in the range of 100.06-101.75% and 99.99-101.95% for Dextromethorphan HBr and Triprolidine respectively. LOD was found to be 2.788μg/ml and 0.330μg/ml for Dextromethorphan HBr and Triprolidine respectively. LOQ was found to be 8.448μg/ml and 1.001μg/ml for Dextromethorphan HBr and Triprolidine respectively. The results revealed that the developed method is suitable for the routine analysis for determination of Dextromethorphan HBr and Triprolidine in Syrup dosage form.

Keywords: Dextromethorphan HBr, Triprolidine RP-HPLC, ICH Q2 (R1).