Development and validation of a new reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms

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 new, 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 Betasil C₁₈ (250 mm x 4.6 mm i.d., 5μ) column using a mobile phase composition of 18 Acetonitrile: 10 mM Na₂ HPO₄ pH 7.0 (55:45 v/v). The flow rate was 1ml/min and the analyte monitored at 233nm. The assay method was found to be linear from 4-24μg/mL. All the validation parameters were within the acceptance range. The developed method was successfully applied to estimate the amount of ezetimibe in tablets.