Formulation of sustained release dosage form of simvastatin and ezetimibe and analytical development by reversed phase high performance liquid chromatography (RP-HPLC)

Ayesha Begum, Pavani Kasu, Sunitha
Int. J. of Farmacia   unpublished
The present investigation relates to a process of preparing sustained release dosage forms containing simvastatin and ezetimibe in co mbination and assay by RP-HPLC method develop ment and validation. Chro matographic separation was achieved on a Water's Xterra colu mn (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 flo w rate of 0.8 ml per minute. The detection was made at 236 n m. The retention time of ezet
more » ... e and simvastatin were 2.6 and 3.4 minutes respectively. The p roposed 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.