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Published on:31 Mar 2013
Indian Journal of Pharmaceutical Education and Research, 2013; 47(1):7-12
Original Article | doi:

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


Authors and affiliation (s):

Ghanshyam Panjwani*1,2, Ragvendra Shetty1, Gautham Shenoy2 and 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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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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