Densitometric Determination of Ezetimibe in the Presence of its Alkaline Degradation Product

Objectives: A simple, accurate, selective and sensitive densitometric method was developed for the determination of ezetimibe in the presence of its alkaline degradation product. Methods: TLC-densitometric separation of ezetimibe from its degradation products was carried out on silica gel plates using ethyl acetate: n-hexane (2:1 v/v) as a developing system. This method depends on quantitative densitometric evaluation of ezetimibe at 230 nm over a concentration range of 1–8 µg/spot. Ezetimibe and its alkaline degradation product were resolved with Rf values of 0.49 and 0.68 respectively. Results: The proposed method has been successfully applied to the analysis of ezetimibe in pharmaceutical dosage form without interference from additives and the results were statistically compared with the reported method. Conclusion: TLC- densitometric technique has provided a simple, straightforward method for separating ezetimibe and its alkaline degradation product simultaneously.