METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DROTAVERINE HYDROCHLORIDE AND ACECLOFENAC IN TABLET DOSAGE FORM BY RP-HPLC

A simple, accurate, sensitive and validated RP-HPLC method for simultaneous determination of Drotaverine hydrochloride and Aceclofenac in combined tablet dosage form has been developed. Separation was carried out on Jasco HPLC system equipped with Hypersil GOLD C18 column (250 x 4.6 mm i.d.) and UV/VIS detector using Methanol: 10 mM potassium dihydrogen phosphate buffer in ratio of (80:20, v/v) as mobile phase and detection was carried out at 231 nm. Ambient temperature conditions were maintained. Results were linear in the range of 4-20 µg/ml for Drotaverine hydrochloride and 4-24 µg/ml for Aceclofenac. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. Results of analysis were validated statistically and by recovery studies.