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Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF SIMULTANIOUS DETERMINATION OF ATORVASTATIN & EZETIMIB IN BULK AND FORMULATION

Wisam Talib Hammadi*

ABSTRACT

Simple, specific, economical and precise high performance liquid chromatographic method for the simultaneous determination of Ezetimibe and Atorvastatin in API (active pharmaceutical ingredient) and formulation has been developed and validated. Chromatography was carried out at 30°C on a pre packed Zorbax SB C18 (5 mm, 250×4.6 mm) column with the 0.02 M Potassium dihydrogen phosphate: Acetonitrile: Methanol (10:40:50, v/v/v) was used as the mobile phase. The UV detection was carried out at 236 nm. The results obtained showed good agreement with the declared contents. Ezetimibe and Atorvastatin separated in less than 10 min with good resolution and minimal tailing and without interference of excipients. The retention times of Ezetimibe and Atorvastatin were 5.7 min and 9.1 min, respectively. The method was linear in the range of 5–50 μg/ml for Ezetimibe concentration with a correlation co-efficient 0.999 and in the range 5–60 μg/ml for Atorvastatin concentrations having correlation co-efficient 0.9994 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 Atorvastatin combination from API and formulations.

Keywords: Ezetimibe, Atorvastatin, Zorbax SB C18, dihydrogen phosphate.


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