Volume :
1
Issue :
1
Abstract :
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 ratio 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, Robustness, Limit of Detection (LOD) and Limit of Quantitation (LOQ) were studied as per the ICH guidelines.