Abstract
A simple, specific and sensitive reverse phase high performance liquid chromatographic method was developed and validated for simultaneous determination of ezetimibe and simvastatin from pharmaceutical dosage forms. The method uses C18 ODS Hypersil column and isocratic elution. The mobile phase composed of acetonitrile:phosphate buffer (pH 4.5, 0.01M) in the ratio of 65:35 v/v was used at a flow rate of 1.0 ml /min. UV detector was programmed at 232 nm for first 10 min and at 238 nm for 10 to 20 min. All the validation parameters were in acceptable range. The developed method was effectively applied to quantitate amount of ezetimibe and simvastatin from tablets. The method was also applied suitably for determining the degradation products of ezetimibe and simvastatin.
Highlights
A simple, specific and sensitive reverse phase high performance liquid chromatographic method was developed and validated for simultaneous determination of ezetimibe and simvastatin from pharmaceutical dosage forms
This prodrug is converted into β hydroxy acid of simvastatin, which is a potent inhibitor of HMG CoA reductase, a key enzyme required for the synthesis of cholesterol in liver[1]
SMV alone can be estimated by various methods reported in the literature such as high performance liquid chromatography (HPLC) with UV detection[3], liquid chromatography coupled with tandem mass www.ijpsonline.com spectroscopy[4], UV spectrophotometry[5]
Summary
HPLC method for determination of EZE from pharmaceutical dosage form has been reported in the literature[6]. Reports are available which describe a stability indicating method for determination of SMV as well as for EZE with its degradation products and impurities[7,8]. Simultaneous determination of SMV and EZE from pharmaceutical dosage form by dual mode gradient liquid chromatography was reported[9]. A Stability indicating HPTLC method for simultaneous estimation of SMV and EZE was reported[10]. The detection limit was defined as the lowest concentration level resulting in a peak area of three times the baseline noise. The quantitation limit was defined as the lowest concentration level that provided a peak area with a signal-to-noise ratio higher than 10
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