Abstract

A RAPID DETERMINATION OF EZETIMIBE IN BULK AND PHARMACEUTICAL FORMULATIONS BY USING RP-HPLC

M. Rama Krishna*, S. Pavan Kumar, MSK. Khurdhus, G. Vaishnavi, M. Mamatha, K. Ravi

ABSTRACT

The objective of the present study was to develop and validated analytical method for the determination of Ezetimibe in bulk and pharmaceutical formulations. A simple, sensitive, precise and accurate, new RP-HPLC method was developed and validated for separation and determination for the Ezetimibe in bulk and pharmaceutical formulations. Ezetimibe was analyzed by Inertsil-ODS C18, (250 mm X 4.6 mm, 5μ) column, Shimadzu LC-20AT Prominence Liquid Chromatography and mobile phase constituted of Methanol:Aectonitrile (70:30, v/v). The flow rate of mobile phase was 1.0 mL/min and the analysis was performed using UV-Visible detector at 230 nm. The Ezetimibe was eluted with in 10 min and retention time was showed 4.536 min. The developed method was validated by the guidelines of ICH Q2R1.The method was found to be linear in the drug concentration range of 20-70 μg/mL. The value of correlation coefficient was found to be 0.999. Method was found good percentage recovery it indicate the method is highly accurate. The method has been successfully applied for determination of Ezetimibe in pharmaceutical dosage form in regular quality control analysis.

Keywords: RP-HPLC, Ezetimibe, Validation, Determination, Formulation.