Development of a Suitable Dissolution Method for the Combined Tablet Formulation of Atorvastatin and Ezetimibe by RP-LC Method

作者：Cansel Kose Ozkan^*; Ozgur Esim; Sevinc Kurbanoglu; Ayhan Savaser; Sibel Ozkan A; Yalcin Ozkan

来源：Current Drug Delivery, 2016, 13(3): 424-432.

DOI：10.2174/1567201813666151201185206

• Atorvastatin calcium
• Combined Tablet
• Dissolution
• Ezetimibe
• RP-LC
• simultaneous determination

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 pK(a) 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.

• 出版日期2016
• 单位中国人民解放军军事医学科学院