Development and Validation of Simvastatin by RP-HPLC Method In Bulk Drug and Pharmaceutical Dosage Forms

A new, simple, specific, sensitive, rapid, accurate and precise RP-HPLC method was developed for the estimation of Simvastatin in bulk and pharmaceutical formulations. Simvastatin was chromatographed on a hypersil C18 column (250x4.6mm I.D., particle size 5 μm) in a mobile phase consisting of sodium dihydrogen phosphate and Acetonitrile in the ratio 40:60 v/v. The mobile phase was pumped at a flow rate of 1.0 ml/min with detection at 239 nm. The detector response was linear in the concentration of 10-200 μg/ml. The intra and inter day variation was found to be less than 2%. The mean recovery of the drug from the solution was 99.39%. The proposed method is simple, fast, accurate, precise and reproducible hence, it can be applied for routine quality control analysis of Simvastatin in bulk and pharmaceutical formulations.