Abstract

ASHFAQ, MUHAMMAD; ULLAHKHAN, ISLAM; SHANAZ QUTAB, SYED  and  NAEEMRAZZAQ, SYED. HPLC DETERMINATION OF EZETIMIBE AND SIMVASTATIN IN PHARMACEUTICAL FORMULATIONS. J. Chil. Chem. Soc. [online]. 2007, vol.52, n.3, pp. 1220-1223. ISSN 0717-9707.  doi: 10.4067/S0717-97072007000300005.

Asimple, precise and sensitive reverse-phase high performance liquid chromatographic method was developed and validated for the simultaneous determination of ezetimibe and simvastatin in pharmaceutical formulations. Chromatographic separation was performed on a Merck Cl 8 columnata wavelength of 240 nm using a mixture of 0.1M ammonium acetate buffer pH 5.0 and acetonitrile in the ratio of (30:70, v/v). The method results in excellent separation with good resolution between the two analytes. The within day variation was between 0.28 and 1.10 % and between day variation was between 0.56 and 1.32 %. The recovery was greater than 99.12 % with RSD less than 1.38 %. The method was validated according to ICH guidelines by performing linearity, accuracy, precision, limits of quantitation and selectivity. The results show mat the method is suitable for its intended use

Keywords : HPLC; acetonitrile; isocratic; ezetimibe; simvastatin.