Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

A stability indicating RP-HPLC method development for determination of ezetimibe in tablet dosage form.

Author(s): Praveen Kumar, Yusra Ahmad and Amitav Ghosh

A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of Ezetimibe in tablets and for determination of content uniformity. An isocratic separation of Ezetimibe was achieved on Zorbax SB C18 (250mm x 4.6mm), 5 μm particle size columns with a flow rate of 1 ml/min and using a UV detector to monitor the eluate at 232nm. The mobile phase consisted of 0.02N ortho phosphoric acid: acetonitrile (20:80 v/v).The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. All degradation products in an overall analytical run time of approximately 6 min with the parent compound Ezetimibe eluting at approximately 3.5 min. Response was a linear function of drug concentration in the range of 1-10 μg/ml (r 2 = 0.9993). Accuracy (recovery) was between 100.80. Degradation products resulting from the stress studies did not interfere with the detection of Ezetimibe and the assay is thus stability-indicating.


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