Development and validation of a reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms
摘要：
Ezetimibe belongs to a group of selective and very effective 2-azetidione cholesterol absorption inhibitors that act on the level of cholesterol entry into enterocytes. A rapid, specific reversed-phase HPLC method has been developed for assaying ezetimibe in pharmaceutical dosage forms. The assay involved an isocratic elution of ezetimibe in a Kromasil 100 C 18 column using a mobile phase composition of water (pH 6.8, 0.05%, w/v 1-heptane sulfonic acid) and acetonitrile (30:70, v/v). The flow rate was 0.5 ml/min and the analyte monitored at 232 nm. The assay method was found to be linear from 0.5 to 50 μg/ml. All the validation parameters were within the acceptance range. The developed method was successfully applied to estimate the amount of ezetimibe in tablets.
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DOI：
10.1016/j.jpba.2005.04.026
被引量：
年份：
2005
Elsevier
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