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DEVELOPMENT AND VALIDATION OF AN RP ? HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ATORVASTATIN AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORMS

Journal: Journal of Atoms and Molecules (Vol.4, No. 3)

Publication Date:

Authors : ; ; ;

Page : 758-768

Keywords : Atorvastatin; Ezetimibe; Internal standard; RP-HPLC estimation.;

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Abstract

Objective: To develop and validate a simple, rapid, accurate and precise, isocratic reverse-phase high-performance liquid chromatographic method [RP-HPLC] for the simultaneous estimation of Atorvastatin and Ezetimibe in pharmaceutical dosage forms. Method: chromatographic separation was achieved by isocratic elution with Phenomenex ODS C18 column with mobile phase composition of Methanol, Acetonitrile and 0.1M KH2PO4 in the ratio of 60:30:10 [v/v], 232nm wavelength at a flow rate of 0.9ml/min. Results: In the developed condition, well retained and resolved chromatograms were observed. All the chromatograms obey system suitability parameters with shortest rum time of 8min. Linearity was found to be 10-100?/ml for both the drugs with respect to internal standard. The developed method was accurate, precise and obeys all the validation parameters. Formulation results of the selected three samples were found to be more than 98%. Conclusion: The propose method was found to be efficient, accurate, precise, specific and economic and is suitable for routine quality control analyses for the simultaneous estimation of Atorvastatin and Ezetimibe.

Last modified: 2014-07-19 17:20:26