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