Development of a selective LC method for the determination of pravastatin sodium

Abstract

A novel, simple and rapid stability-indicating high-performance liquid chromatographic (HPLC) method for pravastatin sodium (PRA) was successfully developed and validated for the assay of in tablets. Chromatographic separation was achieved isocratically on a C-18 column (150 mm x 4.6 mm) utilizing a mobile phase of methanol-phosphate buffer (pH 7; 0.02 M) (57:43, v/v) at a flow rate of 1.0 mL min(-1) with UV detection at 238 nm. A linear response (r = 0.9999) was observed in the range of 1-5 mu g mL(-1). The method showed good recoveries (100.50%) and the relative standard deviation of intra and inter-day were 1.40%. The method can be used for both quality control assay of pravastatin in tablets and for stability studies as the method separates provastatin from its degradation products and tablet excipients.