Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin and simvastatin

Abstract

Statins are effective and often-prescribed drugs for the treatment of hypercholesterolemia. This study shows a simple and fast method validation by reversed-phase high-performance liquid chromatography in the linear range 28 to 52 g/mL to quantify lovastatin, pravastatin sodium or simvastatin in bulk drug or dosage forms. Statins were determined using a C8 endcapped column (250 × 4 mm, 5 m), isocratic mobile phase of acetonitrile and 0.1 phosphoric acid (65:35), 30°C, ultraviolet-diode array detection at λ 238 nm and 1.5 mL/min flow for lovastatin and simvastatin and 1.0 mL/min for pravastatin sodium. The developed method is fast, simple, reliable and shows appropriate linearity (r > 0.999), accuracy (98.8-101.6), precision (relative standard deviation <2) and selectivity toward placebo and/or degradation products in very similar chromatographic conditions for all statins. © 2012 The Author. Published by Oxford University Press. All rights reserved.