STRESS DEGRADATION STUDIES ON MEBEVERINE HYDROCHLORIDE AND DEVELOPMENT OF A VALIDATED STABILITY INDICATING UPLC METHOD

Abstract

A simple, economic, and time-efficient stability-indicating, reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method has been developed for analysis of mebeverine hydrochloride in the presence of both impurities and degradation products generated by forced degradation. When mebeverine hydrochloride was subjected to acid hydrolytic, oxidative, base hydrolysis, photolytic, and thermal stress, degradation was observed only in 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 Waters Acquity C18, 50 mm x 2.1 mm, 1.7 µ particle size column, UV detection at 225 nm and a gradient elution of orthophosphoric acid and acetonitrile as the mobile phase. The method was validated for specificity, precision, linearity, accuracy, and robustness and can be used for quality control during manufacture and for assessment of the stability samples of mebeverine hydrochloride. To the best of our knowledge, a validated stability indicating UPLC method that separates all the six impurities disclosed in this investigation has not been published elsewhere. Total elution time was about 8 min which allowed quantification of more than 100 samples per day.