Development and Validation of a Stability-Indicating Reversed-Phase HPLC Method for Simultaneous Estimation of Rosuvastatin and Ezetimibe from Their Combination Dosage Forms

作者: Anuradha K K Gajjar , Vishal D D Shah

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摘要: A simple, precise and rapid stability-indicating reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed subsequently validated for the simultaneous estimation of Rosuvastatin (RSV) Ezetimibe (EZE) from their combination drug product. The proposed is based on separation two drugs in reverse phase mode using Hypersil C 18 150 x 4.6 mm, 5µ column maintained at a temperature 40°C. optimum mobile consisted 0.05 M phosphate buffer (pH 2.5)-Methanol (45+55, v/v), flow rate 1.0 mL min -1 UV detection was set 242 nm. Rosuvastatin, product were exposed to thermal, photolytic, hydrolytic oxidative stress conditions stressed samples analyzed by method. There no interfering peaks excipients, impurities or degradation products due variable specific RSV EZE presence products. according ICH guidelines. It found be accurate reproducible. Linearity obtained concentration range 5-80 m g both with correlation coefficients 0.99999 0.99994 respectively. % Mean recovery triplicate each level 98% 102% RSD less than 2.0%. can successfully applied quality control bulk manufacturing pharmaceutical dosage forms.

参考文章(19)
Celebier M, Altinoz S, Uyar B, Spectrophotometric determination of rosuvastatin calcium in tablets. Die Pharmazie. ,vol. 62, pp. 411- 413 ,(2007)
Tushar N Mehta, Atul K Patel, Gopal M Kulkarni, Gunta Suubbaiah, Determination of rosuvastatin in the presence of its degradation products by a stability-indicating LC method. Journal of AOAC International. ,vol. 88, pp. 1142- 1147 ,(2005) , 10.1093/JAOAC/88.4.1142
Lata Kothapalli, Asha Thomas, Sumitra Jangam, AD Deshpande, SK Akmar, Reverse phase high performance liquid chromatography method for estimation of ezetimibe in bulk and pharmaceutical formulations Indian Journal of Pharmaceutical Sciences. ,vol. 69, pp. 695- 697 ,(2007) , 10.4103/0250-474X.38482
Margaret Van Heek, Constance Farley, Douglas S Compton, Lizbeth Hoos, Harry R Davis, Ezetimibe selectively inhibits intestinal cholesterol absorption in rodents in the presence and absence of exocrine pancreatic function. British Journal of Pharmacology. ,vol. 134, pp. 409- 417 ,(2001) , 10.1038/SJ.BJP.0704260
P. R. Oliveira, L. Brum Junior, M. Fronza, L. S. Bernardi, S. M. K. Masiero, S. L. Dalmora, Development and Validation of a Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Ezetimibe in Human Plasma and Pharmaceutical Formulations Chromatographia. ,vol. 63, pp. 315- 320 ,(2006) , 10.1365/S10337-006-0749-2
Nikhil R. Shitut, Pasikanti Kishore Kumar, Menon C.A. Vinu, Venkata V. Pavan Kumar, Ramesh Mullangi, Nuggehally R. Srinivas, Thammera Ranjith Kumar, Determination of rosuvastatin in rat plasma by HPLC : validation and its application to pharmacokinetic studies Biomedical Chromatography. ,vol. 20, pp. 881- 887 ,(2006) , 10.1002/BMC.611
Shuijun Li, Gangyi Liu, Jingying Jia, Xiaochuan Li, Chen Yu, Liquid chromatography–negative ion electrospray tandem mass spectrometry method for the quantification of ezetimibe in human plasma Journal of Pharmaceutical and Biomedical Analysis. ,vol. 40, pp. 987- 992 ,(2006) , 10.1016/J.JPBA.2005.07.053
Carlos A Dujovne, Mark P Ettinger, J.Frederick McNeer, Leslie J Lipka, Alexandre P LeBeaut, Ramachandran Suresh, B.o Yang, Enrico P Veltri, Efficacy and safety of a potent new selective Cholesterol absorption inhibitor, Ezetimibe, in patients with primary hypercholesterolemia American Journal of Cardiology. ,vol. 90, pp. 1092- 1097 ,(2002) , 10.1016/S0002-9149(02)02798-4
Hans Lennernäs, Gunnar Fager, Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors. Similarities and differences. Clinical Pharmacokinectics. ,vol. 32, pp. 403- 425 ,(1997) , 10.2165/00003088-199732050-00005