World Journal of
Pharmaceutical and Life Sciences

METHOD DEVELOPMENT AND VALIDATION OF EZETIMIBE BY RP-HPLC IN BULK AND THE PHARMACEUTICAL DOSAGE FORM

Elkaturi Sanjeeth*, Gajavelli Santhosh, Kampati Ravi and Duddagi Suchitra

ABSTRACT

A simple, rapid, precise, accurate and highly sensitive High Performance Liquid Chromatography method has been developed and validated for the determination of Ezetimibe in bulk and pharmaceutical dosage form. Chromatographic separation was achieved on INERTSIL, C18 (150×4.6 ID) 5?m column using mobile phase consisting of a mixture of Acetonitrile and H20 in the ratio of 80:20 and the flow rate was adjusted to 1ml/min with UV detection at 232nm. The retention time of Ezetimibe was found to be 3.560 min. Linearity was observed in the range of 20-60 ?g/ml for Ezetimibe. In the linearity study, the regression equation and coefficient of correlation for Ezetimibe was found to be (y=6.416x+16.91, r²=0.998).The proposed method was validated according to ICH Q2B guidelines. The accuracy of the method was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the method and can be used for routine analysis of pharmaceutical dosage form.

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