A novel analytical method development and validation for the estimation ofsimvastatin in bulk and pharmaceutical dosage forms by RP-HPLC

[摘要] A novel, simple, rapid and precise reverse phase isocratic high performance liquid chromatographic (RP-HPLC) method has been developed for the estimation of Simvastatin in marketed formulations. Estimation of drug in the formulation was done with a C18 column[Agilent ODS UG column, 250mm×4.5mm]using mobile phase of composition Acetonitrile:Methanol:Phosphate buffer pH 3.0 in the ratio of (50: 40: 10v / v) and flow rate was 1.0 mL/min and effluent was monitored with UV detection at 238 nm. The retention time of Simvastatin was observed at 4.3min. The developed method was found to be linear over a concentration range of 5-25μg/mL for Simvastatin. The method was validated according to the guidelines of International Conference on Harmonization (ICH) for specificity, linearity, precision, accuracy and robustness. The proposed method was successfully applied in the estimation of commercial formulations.

[学科分类] 药理学