Abstract

Chromatographic determination of ezitimibe and simvastatin in their pharmaceutical formulation

Author(s): Mamdouh R.Rezk, NaemaM.El Remali, Abdel-Aziz E.Abdel Aleem

Two accurate and precise methods were developed for the Simultaneous determination ofEzitimibe and Simvastatin in their pharmaceutical formulations. A high performance liquid chromatographic method with ultraviolet detection at 240 nm was developed for the separation and determination of the studied drugs using a C18 column. The mobile phase was composed of 0.1Mammoniumacetate buffer (pH4.5): acetonitrile:methanol [35: 55: 10, by volumes].ATLC separation with densitometric detection of both drugs was achieved using toluene: n-butanol: triethylamine (8.5:2.5:0.5, by volumes) as a developing solvent. The proposed methods were validated according to the ICH guidelines. The developed methods were found to be accurate, precise and suitable for the quantitative determination of both the drugs in their pure form, mixtures and in pharmaceutical formulations containing them.