Pharmaceutical preparations of ezetimibe and atorvastatin are generally used to regulate the
lipid level in blood. It decreases the secondary events for patients with high cholesterol and clinical
cardiovascular disease such as non-fatal or fatal heart attack. There is no any pharmacopoeia method
available for the dissolution testing recommended by the FDA. Development of dissolution tests
method is very critical parameter especially for the pharmaceutical preparations that contain Class II
drugs (slightly soluble, good permeable). In the proposed method, the effects of pH and surfactant on the dissolution of
poorly water soluble combined drug therapy with a different pKa values in an in vitro environment is investigated. The
content of our study was designed to answer these open-ended questions. The optimized test conditions achieved under
sink conditions with USP apparatus 2 at a paddle rotation speed of 75 rpm and 900 ml in 0.01 M Acetate buffer (pH= 6.8)
containing 0.45% SDS as a dissolution medium. Quantification of dissolution samples were analyzed with a new fully
validated RP-LC method with UV detection at 242 nm.
Keywords: Atorvastatin calcium, Combined Tablet, Dissolution, Ezetimibe, RP-LC, simultaneous determination.
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