Main Article Content


The present investigation relates to a process of preparing sustained release dosage forms containing simvastatin and ezetimibe in combination and assay by RP-HPLC method development and validation. Chromatographic separation was achieved on a Water’s Xterra column (250 x 4.6, 5 microns) using a mobile phase consisting of Potassium di hydrogen phosphate and methanol in the rat io of 70:30 at a flow rate of 0.8 ml per minute. The detection was made at 236 nm. The retention time of ezetimibe and simvastatin were 2.6 and 3.4 minutes respectively. The proposed method was validated for Accuracy, Specificity, Precision, linearity, Robustn ess, Limit of Detection (LOD) and Limit of Quantitation (LOQ) were studied as per the ICH guidelines.


Ezetimibe Simvastatin Sustained release dosage forms Reversed phase high performance liquid chromatography Limit of detection and limit of quantitation

Article Details