Method development and validation for the estimation of Atorvastatin, Ezitimibe and Fenofibrate in bulk and pharmaceutical dosage forms by RP-HPLC method


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2

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1

Abstract :

A Simple, specific and sensitive an isocratic Estimation by RP-HPLC analytical Method were developed and validated for the quantification Atorvastatin, Ezitimibe and fenofibrate in bulk and Pharmaceutical dosage forms. Quantification was achieved by using the mobile phase (A mixture of 80 volumes of Methanol: 10 volumes of Acetonitrile and 10 volumes of Water.). Inertsil ODS 3V column (250×4.6mm× 5µ) was used as stationary phase. The flow rate was 1.0 ml/min. Measurements were made at a wavelength of 256nm. The average retention times for about 2.230min for Atorvastatin, 3.840 for Ezitimibe and 5.937min for Fenofibrate.and Internal standard was found to be 4.37& 6.70 min. The proposed method was validated for selectivity, precision, linearity and accuracy. The assay methods were found to be linear from 50-150µg/ml. All validation parameters were within the acceptable range. The developed methods were successfully applied to estimate the amount of Atorvastatin, Ezitimibe and fenofibrate
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