Stress degradation studies on ezetimibe and development of a validated stability-indicating HPLC assay

Ezetimibe was subjected to different ICH prescribed stress conditions. Degradation was found to occur in hydrolytic and to some extent in photolytic conditions, while the drug was stable to oxidative and thermal stress. The drug was particularly labile under neutral and alkaline hydrolytic conditions. A stability-indicating HPLC method was developed for analysis of the drug in the presence of the degradation products. It involved a C-8 column and a mobile phase composed of ammonium acetate buffer (0.02 M, pH adjusted to 7.0 with ammonium hydroxide) and acetonitrile, which was pushed through the column in a gradient mode. The detection was carried out at 250 nm. The method was validated for linearity, range, precision, accuracy, specificity, selectivity and intermediate precision.