Abstract | PURPOSE:
Meclizine is an antihistamine and has been widely used for prophylactic treatment of motion sickness. To facilitate its pharmacokinetic study in human subjects, a high performance liquid chromatography-mass spectrometric method employing positive electrospray ionization was developed for the determination of meclizine concentration in human plasma. METHODS:
Meclizine together with the internal standard ( flunarizine) was extracted from 0.1 ml of human plasma by protein precipitation using acetonitrile. The chromatography was performed using a Zorbax SB-C18 column (150 × 2.1mm, 5 μm, Agilent) with the mobile phase consisting of acetonitrile and 0.2% formic acid containing 2mM amino acetate. Multiple reaction monitoring was used for quantification. The validation of the method including sensitivity, linearity, reproducibility and stability was examined. RESULTS: The lower limit of quantification (LLOQ) of the developed assay method for meclizine was 0.5 ng/ml and the linear calibration curve was acquired with R² > 0.99 between 0.5 and 200ng/ml. The intra-day and inter-day variation of the current assay was evaluated with the coefficient of variations (CVs%) within 12.92% at LLOQ and 7.15% for other quality control samples, whereas the mean accuracy ranged from 99.2% to 102.7%. The samples were stable under the storage conditions at least for a month. CONCLUSION: The present method provides a robust, fast and sensitive analytical tool for meclizine in human plasma and has been successfully applied to a clinical pharmacokinetic study in 20 subjects.
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Authors | Zhijun Wang, Shuai Qian, Qizhi Zhang, Moses S S Chow |
Journal | Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
(J Chromatogr B Analyt Technol Biomed Life Sci)
Vol. 879
Issue 1
Pg. 95-9
(Jan 01 2011)
ISSN: 1873-376X [Electronic] Netherlands |
PMID | 21163711
(Publication Type: Journal Article)
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Copyright | Copyright © 2010 Elsevier B.V. All rights reserved. |
Chemical References |
- Acetonitriles
- Formates
- formic acid
- Meclizine
- Flunarizine
- acetonitrile
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Topics |
- Acetonitriles
(chemistry)
- Chromatography, High Pressure Liquid
(methods)
- Drug Stability
- Flunarizine
(analysis)
- Formates
(chemistry)
- Humans
- Least-Squares Analysis
- Mass Spectrometry
(methods)
- Meclizine
(blood, pharmacokinetics)
- Reproducibility of Results
- Sensitivity and Specificity
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