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SIMULTANEOUS ESTIMATION AND VALIDATION OF EZETIMIBE AND GLIMEPRIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

B. Siddartha and Radhika Malipelli

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Ezetimibe and Glimepride in pharmaceutical dosage form. The column used was AltimaC18 (150mm x 4.6 mm, 5m) in isocratic mode, with mobile phase containin g phosphate buffer and acetonitrile (20:80v/v). The buffer is prepared by adding 1.36gm of potassium dihyrogen ortho phosphate in a 1000ml of volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then added 1ml of triethylamine then pH adjuste d to 4.8 with dil. orthophosphoric acid solution. The flow rate was 1.0ml/ min and effluents were monitored at 228 nm. The retention times of Ezetimibe and Glimepride were found to be 2.149 min and 2.717 min, respectively. The linearity for Ezetimibe and Glimepride were in the range of 50-300 μg/ml and 5-30 μg/ml respectively. The recoveries of Ezetimibe and Glimepride were found to be 98.13 to 100.90% w/v and 98.80 to 100.45% w/v, respectively. The proposed method was validated and successfully applied to the estimation of Ezetimibe and Glimepride in combined tablet dosage forms.