Stability-Indicating Liquid Chromatographic Method for the Simultaneous Determination of Rosuvastatin and Ezetimibe from Pharmaceuticals and Biological Samples

Abstract

Fixed dose combinations of ezetimibe and rosuvastatin are well known to provide significantlysuperior efficacy to rosuvastatin alone in lowering total cholesterol, and triglyceride levels. Therefore, inthis recent work, we prepared fixed dose (10 mg/10 mg) ezetimibe and rosuvastatin tablet formulations,and a simple, selective and we established and validated rapid chromatographic method for the sensitiveand simultaneous determination of rosuvastatin and ezetimibe. We performed the separation on ZorbaxSB-C18 (100 mm x 4.6 mm, 3.5 µm particle size) column at 30 oC with a mobile phase that has acomposition as water containing 0.1% H3PO4:methanol:acetonitrile (50:25:25 v/v/v) at 1.2 mL/min flowrate. We further performed validation studies according to ICH guidelines. Furthermore, we exposedrosuvastatin and ezetimibe to degradation conditions. We plotted peak area vs. concentration graphs forrosuvastatin and ezetimibe and used for defining the linearity of the detector response. In this suggestedmethod, we observed linear relationships varying from 0.05 to 50 µg/mL for ezetimibe concentrations andfrom 0.05 to 25 µg/mL for rosuvastatin concentrations. We found the limit of detection values forrosuvastatin and ezetimibe as 0.006 and 0.008 µg/mL, respectively. Moreover, we further used theestablished method for to the analysis of ezetimibe and rosuvastatin from real spiked samples of rabbitserum.