Development and Validation of Reverse Phase High Performance Liquid Chromatography Method for the Estimation of Pravastatin Sodium in Tablet Dosage Form.

Pravastatin sodium is a HMG Co A reductase inhibitor, used as a lipid lowering agent. A simple, precise, rapid, accurate and cost effective high performance liquid chromatography (HPLC) method was successfully developed and validated for estimation of pravastatin sodium in tablet dosage form. Chromatographic separation was achieved on a Luna C18 column (250 mm X 4.6 mm) utilizing mobile phase methanol and aqueous solution of o-phosphoric acid (0.6% v/v) at a flow rate of 1.0 ml/min with UV detection at 239 nm. A linear response was observed in the range of 14–26 μg/ml with correlation co-efficient of 0.9997. The mean percent recoveries of pravastatin sodium in tablet formulations were found to be in the range of 98.9 -100.2%. The intra day and inter day precision was found to be within limits. The proposed method has adequate specificity, sensitivity and reproducibility for quality control assay of pravastatin sodium in tablet dosage form without any interference from excipients.