Simultaneous Estimation of Simvastatin and Ezitimibe by UV Spectroscopy

Simvastatin (SMV) and Ezitimibe (EZT) are the antihyperlipidemic drug belonging to HMG-CoA reductase inhibitor and helps to reduce harmful cholesterol levels in blood. A rapid, specific and economic UV spectrophotometric method has been developed using Methanol and distilled water in the ratio of (40:60) as a solvent for simultaneous determination of Simvastatin and Ezetimibe content in bulk and pharmaceutical dosage formulations. The absorbance values at 246 nm and 229 nm were used for the estimation of Ezetimibe and Simvastatin. The absorption maxima of Ezetimibe and simvastatin shown at 246 nm and 229 nm and methanol and distilled water in the ratio of (40:60) was used as solvent. This method obeyed Beer's law in the concentration range of 3-18 μg /ml for simvastatin and 5-30 μg /ml for Ezetimibe. The Simultaneous Estimation method was developed and validated according to ICH guidelines for linearity, precision, accuracy, LOD and LOQ. Simvastatin found to be linear within concentration range of 3-18 μg/ml with regression coefficient of 0.998 and Ezitimibe found to be linear within concentration range of 5-30 μg/ml with regression coefficient of 0.999. The percentage RSD value for the SMV at the concentration of 3, 6 and 9 μg/ml and their average % RSD value were 0.350, 0.168 and 0.286 while for the EZT the concentration of 5, 10 and 15 μg/ml and their average % RSD value were 0.387, 0.170 and 0.282. The average % recoveries for three different concentrations was found to be 95.50 % for SMV and 96.60 % for EZT. The limit of detection and limit of quantification were found to be 0.33 μg/ml and 1.33 μg/ml for Simvastatin and 1.007 μg/ml and 4.04 μg/ml for Ezitimibe respectively by proposed UV spectrophotometric method. The results of validation parameters indicates that the developed method was also found to be accurate, precise and sensitive and such simple & economic method can be used for the simultaneous estimation of Simvastatin and Ezitimibe. The obtained results proved that the method can be employed for the routine analysis of simvastatin and Ezetimibe in bulks as well as in the commercial formulation.