Microemulsion Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe in Their Combined Dosage Forms

A rapid HPLC procedure using a microemulsion as an eluent was developed and validated for analytical quality control of antihyperlipidemic mixture containing simvastatin (SIM) and ezetimibe (EZT) in their pharmaceutical preparations. The separation was performed on a column packed with cyano bonded...

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Main Authors: Mohammed E. A. Hammouda, Mohamed A. Abu El-Enin, Dina T. El-Sherbiny, Dalia R. El-Wasseef, Saadia M. El-Ashry
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:Journal of Analytical Methods in Chemistry
Online Access:http://dx.doi.org/10.1155/2013/132836
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author Mohammed E. A. Hammouda
Mohamed A. Abu El-Enin
Dina T. El-Sherbiny
Dalia R. El-Wasseef
Saadia M. El-Ashry
author_facet Mohammed E. A. Hammouda
Mohamed A. Abu El-Enin
Dina T. El-Sherbiny
Dalia R. El-Wasseef
Saadia M. El-Ashry
author_sort Mohammed E. A. Hammouda
collection DOAJ
description A rapid HPLC procedure using a microemulsion as an eluent was developed and validated for analytical quality control of antihyperlipidemic mixture containing simvastatin (SIM) and ezetimibe (EZT) in their pharmaceutical preparations. The separation was performed on a column packed with cyano bonded stationary phase adopting UV detection at 238 nm using a flow rate of 1 mL/min. The optimized microemulsion mobile phase consisted of 0.2 M sodium dodecyl sulphate, 1% octanol, 10% n-propanol, and 0.3% triethylamine in 0.02 M phosphoric acid at pH 5.0. The developed method was validated in terms of specificity, linearity, lower limit of quantification (LOQ), lower limit of detection (LOD), precision, and accuracy. The proposed method is rapid (8.5 min), reproducible (RSD < 2.0%) and achieves satisfactory resolution between SIM and EZT (resolution factor = 2.57). The mean recoveries of the analytes in pharmaceutical preparations were in agreement with those obtained from a reference method, as revealed by statistical analysis of the obtained results using Student’s t-test and the variance ratio F-test.
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publishDate 2013-01-01
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series Journal of Analytical Methods in Chemistry
spelling doaj-art-fd03abd51eeb495bbb728a28c40663f82025-08-20T02:22:38ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732013-01-01201310.1155/2013/132836132836Microemulsion Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe in Their Combined Dosage FormsMohammed E. A. Hammouda0Mohamed A. Abu El-Enin1Dina T. El-Sherbiny2Dalia R. El-Wasseef3Saadia M. El-Ashry4Department of Medicinal Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura 35516, EgyptDepartment of Medicinal Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura 35516, EgyptDepartment of Medicinal Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura 35516, EgyptDepartment of Medicinal Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura 35516, EgyptDepartment of Medicinal Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura 35516, EgyptA rapid HPLC procedure using a microemulsion as an eluent was developed and validated for analytical quality control of antihyperlipidemic mixture containing simvastatin (SIM) and ezetimibe (EZT) in their pharmaceutical preparations. The separation was performed on a column packed with cyano bonded stationary phase adopting UV detection at 238 nm using a flow rate of 1 mL/min. The optimized microemulsion mobile phase consisted of 0.2 M sodium dodecyl sulphate, 1% octanol, 10% n-propanol, and 0.3% triethylamine in 0.02 M phosphoric acid at pH 5.0. The developed method was validated in terms of specificity, linearity, lower limit of quantification (LOQ), lower limit of detection (LOD), precision, and accuracy. The proposed method is rapid (8.5 min), reproducible (RSD < 2.0%) and achieves satisfactory resolution between SIM and EZT (resolution factor = 2.57). The mean recoveries of the analytes in pharmaceutical preparations were in agreement with those obtained from a reference method, as revealed by statistical analysis of the obtained results using Student’s t-test and the variance ratio F-test.http://dx.doi.org/10.1155/2013/132836
spellingShingle Mohammed E. A. Hammouda
Mohamed A. Abu El-Enin
Dina T. El-Sherbiny
Dalia R. El-Wasseef
Saadia M. El-Ashry
Microemulsion Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe in Their Combined Dosage Forms
Journal of Analytical Methods in Chemistry
title Microemulsion Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe in Their Combined Dosage Forms
title_full Microemulsion Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe in Their Combined Dosage Forms
title_fullStr Microemulsion Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe in Their Combined Dosage Forms
title_full_unstemmed Microemulsion Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe in Their Combined Dosage Forms
title_short Microemulsion Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe in Their Combined Dosage Forms
title_sort microemulsion liquid chromatographic method for simultaneous determination of simvastatin and ezetimibe in their combined dosage forms
url http://dx.doi.org/10.1155/2013/132836
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