Analytical method development and validation of assay test of pravastatin sodium tablets

Abstract

A simple, accurate, precise and stability indicating Ultra performance liquid chromatographic method for determination of pravastatin sodium in tablet dosage form. The separation was carried on Acquity UPLC ® HSS C18, 2.1 × 100mm, 1.8µm ID column, with mobile phase comprising of mixture of pH 5.5 buffer: methanol in the ratio of 30 : 70 v/v, as the mobile phase at a flow rate  0.2 ml/min and the detection was carried out using UV-visible detector at 238nm. The method was validated by evaluation of different parameters such as accuracy, precision, linearity, ruggedness, robustness, filter equivalency, solution stability. The retention time were found to be 1.5 min. Calibration curves were linear with correlation coefficient (r2) 0.999. The Percent assay of Pravastatin sodium tablet was found to be 98.4%. The developed methods were validated as per the ICH guidelines. Keywords: Pravastatin sodium (PVS), UPLC, Method Validation.