Abstract
A simple, precise, accurate and rapid isocratic reversed phase high performance liquid chromatographic method was developed and validated for the simultaneous estimation of simvastatin and ezetimibe from their combination drug products. Chromatographic separation was achieved at ambient temperature using mu-Bondapak C-18, 3.9 x 300 mm, 10 mu m i.d. column with a simple mobile phase consisted of methanol : water (78 : 22, v/v), delivered at a flow rate of 0.8 mL min(-1) and wavelength of detection at 238 am. The method has shown adequate separation with good resolution in which the retention time of ezetimibe and simvastatin were 4.4 and 8.3 min respectively. The method was found linear over the range of 0.6-60 mu g mL(-1) (r = 0.9999) for simvastatin and 0.5-50 mu g mL(-1) (r = 0.9999) for ezetimibe. The intra-and inter-day RSD (n = 6) was <= 2.0%. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. The proposed method was successfully applied for simultaneous determination of these drugs in combined dosage forms thus enabling the utility of the method for routine analysis.