Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Simvastatin in Bulk and Tablet Dosage form

A reverse phase high performance liquid chromatography (RP-HPLC) method for the estimation of simvastatin in bulk and tablet dosage form was developed using C₁₈ Column (250×4.5mm), with phosphate buffer (pH 4.5) and acetonitrile (75: 25 v/v) as mobile phase. The optimum wavelength detection and quantitation was 238 nm using an ultra-violate detector and flow rate was 1 ml/min. The retention time was found to be 15.87 min. Simvastatin was subjected to stress test conditions like oxidation, photolysis, alkaline and acid hydrolysis and thermal degradation. The amount of drug remaining after degradation study was observed 97.09, 94.19, 95.51, 94.96 and 95.95% in acidic, alkaline, photo degradation, oxidative and thermal degradation respectively. The method was validated for parameter such as linearity, precision, accuracy, range, specificity and robustness as per ICH guideline. The limit of detection and limit of quantification was found to be 4.33 and 21.67 μg/ml respectively. The parentage recovery was found to be 100.39%.The linearity was established in the range of 50–150 μg/ml with r² 0.993.