Analytical method development and validation for the analysis of verapamil hydrochloride and its related substances by using ultra perfomance liquid chromatography

摘要

A novel, economic, and time-efficient stability-indicating, reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method has been developed for the analysis of verapamil hydrochloride in the presence of both impurities and degradation products generated by forced degradation. When verapamil hydrochloride was subjected to acid hydrolysis, oxidative, base hydrolysis, photolytic, and thermal stress, degradation was observed only in oxidative and base hydrolysis. The drug was found to be stable to other stress conditions. Successful chromatographic separation of the drug from impurities formed during synthesis and from degradation products formed under stress conditions was achieved on a Shimpak XR ODS, 75 mm x 3.0 mm, 1.7 mu particle size column, UV detection at 278 nm and a gradient elution of ammonium formate, orthophosphoric acid and acetonitrile as mobile phase.