Article · Volume 47, Issue 1 · pp. 7–12

Development and Validation of a new Reversed-phase HPLC Method for the Determination of Ezetimibe in Pharmaceutical Dosage forms

Ghanshyam Panjwani^1,2, Ragvendra Shetty¹, Gautham Shenoy², Dinesh Dhamecha³

¹Ecron Acunova Manipal Acunova Clinical Research Centre, 4th Floor, Shirdi Sai Baba Cancer Hospital, Manipal - 576104, Karnataka.
²Department of Pharmaceutical Chemistry Manipal University, Manipal. edu, Madhav Nagar, Manipal - 576104, Karnataka.
³Genba Sopanrao Moze College of Pharmacy, Wagholi, Pune - 412207.

Abstract

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 C (250 mm x 4.6 mm i.d., 5μ) column using a mobile phase composition of 18 Acetonitrile: 10 mM Na HPO 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 2 4 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.

Keywords: Ezetimibe; HPLC; validation

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