Abstract

HPLC METHOD DEVELOPMENT, METHOD DETERMINATION AND METHOD VALIDATION OF DOSAGE FORM OF EZETIMIBE

N. Suneel Kumar*, B. Thirupathi Rao, P. Muralikrishna and CH. Narasimha Rao

Abstract

To develop a method determination and method validation of dosage form of Ezetimibe and stability-indicating liquid chromatographic analytical method for assay of Ezetimibe and for determination of the content uniformity of a tablet formulation. Methods: This paper aimed to develop a simple, sensitive, and rapid chromatographic procedure for Ezetimibe. The mobile phase of 0.1% ortophosphoric acid and acetonitrile (50:50) at flow rate of 1 mL/min on reverse phase. The separation was carried out on a 250-mm × 4.6-mm inside-diameter reverse-phase column (Zorbax SB-C18, 5 μm), Water: Acetonitrile: Methanol (40:50:10, v/v) as a diluent. Results: Total analytical run time for selecting The assays exhibited good linearity (r 2 = 0.9999) over the studied range of 2 20 μg/ml to 80 μg/ml. the LOD and LOQ values of the analytical method are 0.1 μg/ml and 0.2 μg/ml respectively which correspond to 0.2% and 0.4% of working concentration Overall %RSD of replicate sets of method and intermediate precision study is 0.67, the difference between mean % assay values of method precision and Intermediate precision is 0.4. The performance of the method was validated according to the present ICH guidelines.

Keywords: Ezetimibe, HPLC, Method validation, stability.