Abstract

The present study indicates a simple, accurate and precise HPLC method for the estimation of  Simvastatin, inhibitor of 3-hydroxy 3-methyl glutaryl  coenzyme A. HMG- CoA reductase, responsible for catalyzing the conversion of HMG- CoA to mevalonate, is an early and rate limiting step in cholesterol biosynthesis.  The mobile phase used was acetonitrile:water in a ratio of 60:40 at a wavelength of 240 nm. The separation was carried out using a C18 Phenomenex Luna column (250mm × 4.6mm×5µm). This method obeyed linearity in the Beer’s Lambert range for the concentration range of 10-100μg/ml for Simvastatin. The proposed method has been validated statistically as per the ICH guidelines for linearity, accuracy, precision, specificity, LOD and LOQ. The above method was validated and  the results were well with in the limit of accuracy 100±2 and % RSD is with in 2. The  above method developed and validated successfully for the quantitative routine analysis of Simvastatin in bulk and pharmaceutical dosage form. This study thus exploits the possibility for determining Pharmacokinetic data of  Simvastatin which may be required in clinical study in near future.