STABILITY INDICATING VALIDATED METHOD DEVELOPMENT FOR SIMULTANEOUS DETERMINATION OF EZETIMIBE & SIMVASTATIN BY RP-HPLC

Praveen Kumar* and Kaushal Kishore Chandrul

ABSTRACT

Simple, specific, economical and precise high performance liquid chromatographic method for the simultaneous determination of Ezetimibe and Simvastatin in API (active pharmaceutical ingredient) and formulation has been developed and validated. Chromatography was carried out at 30◦C on a prepacked Zorbax SB C18 (5 mm, 250 x 4.6 mm) column with a mobile phase consisting of Acetonitrile: Methanol: Orthophosphoric acid (0.1%, pH 4), (70:25:5 v/v) . The UV detection was carried at 236 nm. The results obtained showed good agreement with the declared contents. Ezetimibe and Simvastatin separated in less than 10 minutes with good resolution and minimal tailing and without interference of excipients. The retention times of Ezetimibe and Simvastatin were 2.75 min and 6.9 min, respectively. The method was linear in the range of 2.5–15 μg/ml for Ezetimibe concentration with a correlation co-efficient 0.9996 and in the range 2.5–25 μg/ml for Simvastatin concentrations having correlation co-efficient 0.9998 and the recovery was 99-102%. The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity and system suitability were met in all cases. The proposed method can be used for quantitative determination of Ezetimibe and Simvastatin combination from API and formulations.

Keywords: Ezetimibe, Simvastatin, Method Development, Validation, RP-HPLC.