Pravastatin sodium (PRS) is a HMG Co A reductase inhibitor, used as a lipid lowering agent. Two simple, sensitive and economical UV spectrophotometric methods have been developed for the estimation of pravastatin sodium in bulk drug and pharmaceutical tablet dosage forms. Methods were based on the first order derivative spectroscopy and area under curve method. Both method obeyed Beer's law in the concentration range of 10–20 μg/ml. The results obtained with the proposed methods are in good agreement with labeled amounts when tablet dosage forms were analyzed. The proposed methods were validated for analytical method validation parameter as per ICH and US FDA guidance documents. The proposed methods have adequate specificity, sensitivity and reproducibility for quality control assay of pravastatin sodium in bulk and tablet dosage form without any interference from excipients.
Pravastatin sodium, Derivative spectroscopy, Area under curve method, Analytical method validation
