Abstract
Simple, specific, economical and precise high performance liquid chromatographic method for the simultaneous determination of ezetimibe and Atorvastatin in API (active pharmaceutical ingredient) and formulation has been developed and validated. Chromatography was carried out at 30°C on a prepacked Zorbax SB C18 (5 mm, 250×4.6 mm) column with the 0.02 M Potassium dihydrogen phosphate: Acetonitrile: Methanol (10:40:50, v/v/v) was used as the mobile phase. The UV detection was carried at 236 nm. The results obtained showed good agreement with the declared contents. Ezetimibe and Atorvastatin separated in less than 10 min with good resolution and minimal tailing and without interference of excipients. The retention times of ezetimibe and Atorvastatin were 5.7 min and 9.1 min, respectively. The method was linear in the range of 5–50 μg/ml for Ezetimibe concentration with a correlation co-efficient 0.9992 and in the range 5–60 μg/ml for Atorvastatin concentrations having correlation co-efficient 0.9994 and the recovery was 99-102%. The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity and system suitability were met in all cases. The proposed method can be used for quantitative determination of Ezetimibe and Atorvastatin combination from API and formulations.
Highlights
IntroductionAtorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl
Atorvastatin (ATV) is chemically [R-(R*,R*)]-2-(4-flurophenyl)- β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt trihydrate.Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutarylCoenzyme A (HMG-CoA) reductase
Ezetimibe is metabolized into its glucuronide in the liver and small intestine, which is active in prevention of absorption of cholesterol
Summary
Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl. This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate limiting step in cholesterol biosynthesis [1,2]. It is a selective cholesterol absorption inhibitor used in the treatment of primary hypercholesterolemia. It inhibits the absorption of biliary and dietary cholesterol from small intestine without affecting absorption of fat soluble vitamins, triglycerides and bile acids. Ezetimibe is metabolized into its glucuronide in the liver and small intestine, which is active in prevention of absorption of cholesterol. Ezetimibe does not have significant pharmacokinetic interactions with other lipid lowering drugs as it does not influence the activity of cyotochrome
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