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Determination of dehydroandrographolide succinate in human plasma by liquid chromatography tandem mass spectrometry (LC-MS/MS): Method development, validation and clinical pharmacokinetic study.

Abstract
A LC-MS/MS method was developed and validated for the determination of dehydroandrographolide succinate (DAS), a traditional Chinese medicine derivative used for the treatment of pneumonia, upper respiratory tract infection, and chronic bronchitis. Following protein precipitation, DAS was detected by ion transition at m/z 531.2/99.0 in multiple reaction monitoring mode with negative electrospray ionization-tandem mass spectrometry. The limit of detection was 0.5ng/mL, and the lower limit of quantification was 10ng/mL in human plasma. Good linearity was maintained over the range of 10-5000ng/mL, and the correlation coefficient was better than 0.99. The accuracy ranged from 95.3% to 113%, RSD from 0.928% to 6.47%, for the within- and between-run analysis at all QC levels. The recovery ranged from 85.5% to 93.4% and the matrix effect from 107% to 119%. No significant carryover and good stability were found during method validation. The developed method was successfully applied to the determination of DAS in human plasma in a pharmacokinetic study following intravenous infusion of potassium sodium DAS to nine healthy volunteers.
AuthorsShuijun Li, Ding Yang, Mengqi Zhang, Juzhen Zhou, Rui Li, Chuan Lu, Yun Liu, Yanmei Liu, Yiping Wang, Chen Yu
JournalJournal of chromatography. B, Analytical technologies in the biomedical and life sciences (J Chromatogr B Analyt Technol Biomed Life Sci) Vol. 878 Issue 24 Pg. 2274-9 (Aug 15 2010) ISSN: 1873-376X [Electronic] Netherlands
PMID20638916 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright 2010 Elsevier B.V. All rights reserved.
Chemical References
  • Diterpenes
  • Drugs, Chinese Herbal
  • Succinates
  • dehydroandrographolide
Topics
  • Adult
  • Chi-Square Distribution
  • Chromatography, Liquid (methods)
  • Diterpenes (blood, pharmacokinetics)
  • Drug Stability
  • Drugs, Chinese Herbal
  • Female
  • Humans
  • Male
  • Reproducibility of Results
  • Succinates (blood, pharmacokinetics)
  • Tandem Mass Spectrometry (methods)

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