Development and Validation of a High Performance Liquid Chromatography with Ultraviolet Detector Method for Determination of Rosuvastatin in Rat Plasma

Rosuvastatin is an effective 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor and it is widely prescribed in the treatment of patients with hypercholesterolaemia. A simple high performance liquid chromatography method for determination of rosuvastatin in rat plasma was developed over the range of 50-8000 ng/mL. Protein precipitation with acetonitrile was used as sample preparation. Chromatographic separation was achieved on a C18 (4.6 x 150 mm, 5 mu m) column with acetonitrile-0.1% trifluoroacetic acid in water (40: 60, v/v). The ultraviolet detector was used in this study, with the detection wavelength of 242 nm. Linear calibration was obtained with correlation coefficients r > 0.99. The CV of the precision measurements was less than 5%. The accuracy of the method ranged from 94.7 to 105.6%. Mean recoveries of rosuvastatin in rat plasma were in the range of 93.5-96.7%. The method was successfully applied to the pharmacokinetic study of rosuvastatin in rats after oral and intravenous administration. The absolute bioavailability of rosuvastatin was calculated to be 39.8%.