Development and Validation of RP-HPLC Method for Quantitative Analysis of Simvastatin in Pure and Pharmaceutical Formulations

Author(s): R. B. Desireddy, G. Naga Sowjanya, Ch. T. Lalitha Kumari, S. Sri Hariteja, K. Gopaiah, P. Yehoshuva and S. Brahmam

A simple, specific, accurate and precise reverse phase liquid chromatographic method was developed and validated for the determination of Simvastatin in pure and pharmaceutical formulations. A phenomenex C-18, 5 μm column having 250 mm x 4.6 mm internal diameter, isocratic mode with mobile phase containing ethanol: Acetonitrile: Water (30 : 30 : 40 v/v) was used. The flow rate was 1.0 mL/min. and effluents were monitored at 271 nm. The retention time of simvastatin was 2.05 min. The method was validated for parameters as per ICH guidelines. Due to its simplicity and accuracy, the method can be used for routine quality control of Simvastatin in bulk and pharmaceutical formulations.

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