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STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF SIMVASTATIN IN BULK AND TABLET DOSAGE FORM

Vinit Chavhan and Minal Ghante

Simvastatin (SMV) is antihyperlipidemic drug belonging to HMG-CoA reductase inhibitor and helps to reduce harmful cholesterol levels in blood. Simple and economic stability indicating UV spectrophotometric method of Simvastatin in bulk and tablet dosage form has been developed and validated as per ICH guidelines.The absorption maxima of Simvastatin shown at 237 nm and methanol was used as diluent. Stability studies of Simvastatin were carried out under acidic, basic, neutral, oxidative, thermal and photolytic conditions in developed method as per stability indicating assays and validated according to ICH guidelines for linearity, precision, accuracy, LOD and LOQ. Simvastatin found to be linearwithin the concentration range of 3-18 μg/ml with regression coefficient of 0.9998. The percentage RSD values of precision study were less than 2 percent while developed method capable of recovering good amount of drug (% Recovery) in presence of excipients and LOD and LOQ values of SMV were 0.73 μg/ml and 2.07 μg/ml respectively. 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 analysis of formulation of Simvastatin in quality control laboratories as stability indicating assay method