title: Development of a Suitable Dissolution Method for the Combined Tablet Formulation of Atorvastatin and Ezetimibe by RP-LC Method.
abstract: 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.
authors.affiliation: Gulhane Military Medical Academy, Department of Pharmaceutical Technology, Etlik, Ankara, Turkey. ckozkan@gata.edu.tr.
authors.forename: Kose
authors.initials: K
authors.lastname: Ozkan Cansel
authors.forename: Esim
authors.initials: E
authors.lastname: Ozgur
authors.forename: Kurbanoglu
authors.initials: K
authors.lastname: Sevinc
authors.forename: Savaser
authors.initials: S
authors.lastname: Ayhan
authors.forename: Sibel A
authors.initials: SA
authors.lastname: Ozkan
authors.forename: Ozkan
authors.initials: O
authors.lastname: Yalcin
mesh_terms: D000924:Anticholesteremic Agents / Q000737:chemistry; D000069059:Atorvastatin / Q000737:chemistry*; D002853:Chromatography, Liquid; D004338:Drug Combinations; D065546:Drug Liberation; D000069438:Ezetimibe / Q000737:chemistry*; D006863:Hydrogen-Ion Concentration; D007700:Kinetics; D011136:Polysorbates / Q000737:chemistry; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry; D012995:Solubility; D013501:Surface-Active Agents / Q000737:chemistry; D013607:Tablets
chemical_list: D000924:Anticholesteremic Agents; D004338:Drug Combinations; D011136:Polysorbates; D013501:Surface-Active Agents; D013607:Tablets; D012967:Sodium Dodecyl Sulfate; D000069059:Atorvastatin; D000069438:Ezetimibe