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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2007, Vol. 12 ›› Issue (7): 819-823.

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Determination of rosuvastatin calcium in human plasma by LC-MS/MS and its clinical pharmacokinetics in Chinese healthy volunteers

LI Chun-ying1, ZHANG Yu-ying1, DING Li2   

  1. 1Guangzhou Institute for Drug Control, Guangzhou 510160, Guangdong, China;
    2Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, Jiangsu, China
  • Received:2006-12-11 Revised:2007-03-02 Online:2007-07-26 Published:2020-10-27

Abstract: AIM: To establish a rapid and sensitive LC-MS/MS method for the analysis of rosuvastatin calcium in plasma and study the pharmacokinetics of rosuvastatin on China healthy volunteers. METHODS: Plasma samples containing rosuvastatin calcium and fluvastatin sodium were extracted with liquid-liquid extraction, followed by liquid chromatographic separation and on-line MS/MS using turboionspray ionization as an interface detection by the multi-reaction monitoring. RESULTS: The limit of quantitation of method for rosuvastatin calcium was 0.03 ng/mL, the calibration curves in plasma were linear over the range of 0.03 to 60 ng/mL and within-batch and between-batch variation over the range were less than 10%. CONCLUSION: The method is shown to be accurate and convenient, and suitable for pharmacokinetic studies of rosuvastatin calcium.

Key words: rosuvastatin calcium, liquid chromatography tandem mass spectrometry, pharmacokinetics, plasma concentration

CLC Number: