ABSTRACT

A reverse phase liquid chromatographic method was developed for the determination of purity of glyburide drug substance and drug product in bulk samples and pharmaceutical dosage form in the presence of its impurities and degradation product. This method is capable of separating all the related substance of glyburide along with impuri-ties. This method also can be used for the estimation of assay of glyburide in drug substance as well as in drug pro-duct. The method was developed using Inertsil C8 Octyl decane silane (250 x 4.0 mm 5.0μm) column, buffer pH 5.3: acetonitrile in the ratio of 60:40 %v/v used as mobile phase. The elution compounds were monitored at 230 nm. The method was validated as per ICH guidelines demonstrating to the accurate and precise within the correspon-ding linear range of impurities from LOQ to 200%. The specificity of the method was investigated under different stress conditions including hydrolytic, oxidative, photolytic and thermal as recommended by ICH guidelines. Rele-vant degradation was found to be significantly in acid, hydrolysis and oxidative condition. Robustness against small modification in column oven temperature, flow rate and percentage of the mobile phase composition was ascerta-ined. Limit of detection and limit of quantification were also determined.