DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF DROTAVERINE HYDROCHLORIDE

Abstract

A simple accurate and reproducible stability indicating RP-HPLC method with UV-visible spectrophotometer was
developed for the analysis of Drotaverine hydrochloride. Efficient chromatographic separation was achieved on SHISEIDO
CAP CELL PACK C18 column 250mm × 4.6 mm id, 5?m using 0.2% v/v formic acid and methanol (55:45) as mobile phase
at floe rate 1 ml/min with column temperature 25º C. The method showed linearity over the range 40-180 ?g/ml with
correlation coefficient 0.9998.The drotaverine hydrochloride drug was subjected to acidic, alkaline, neutral, oxide, thermal
and photolytic stress conditions. Drotaverine was found to be degrading significantly in alkaline, acid, oxide and photolytic
stress conditions. Drotaverine hydrochloride was stable in neutral and thermal stress conditions. The developed method was
validated according to ICH guidelines with respect to linearity, specificity, accurate, precise and robustness.