Study of stressed degradation behavior of drotaverine and development of a validated stability-indicating HPLC assay method

摘要

A stability indicating HPLC method was developed for the analysis of Drotaverine in the presence of its degradable products using C18 column. Mixture of methanol and ammonium acetate (0.1 M, pH 5) in the ratio of 60:40 (v/v) was taken as mobile phase, at flow rate of 1.5 ml min-1. Detection was carried out at wavelength 319nm using photodiode array detector. Drotaverine was subjected to different ICH prescribed stress conditions like acid, alkali, neutral hydrolysis, oxidation, dry heat, and Sunlight. In study it was observed that significant degradation was found in alkali, oxidation and photolytic conditions. The drug was labile under acidic and neutral hydrolytic conditions but stable to thermal stress conditions. The degradation products of Drotaverine in different conditions were well resolved from the pure drug with significant differences in their retention time values. The developed assay method was validated according to ICH guideline and found accurate, precised and specific as all the results were within the acceptance limit.