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2013 (v.21 no.2)

The Journal of Korean Society for Clinical Pharmacology and Therapeutics

Korean Society for Clinical Pharmacology and Therapeutics
ISSN: 1225-5467

  • Validation of LC-MS/MS Method for Determination of Bivalirudin in Human Plasma: Application to a Pharmacokinetic Study

    Yo Han Kim, Hyun Jeong Park, Hee Youn Choi, Hyeong-Seok Lim, Kyun-Seop Bae

    J Korean Soc Clin Pharmacol Ther | v.21, no.2, pp.166-173, Dec, 2013


    Background: Bivalirudin is a direct thrombin inhibitor for patients with unstable angina undergoing
    percutaneous coronary intervention.
    Methods: A sensitive liquid chromatography-tandem mass spectrometry (LC/MS/MS) method was
    developed and validated for the determination of bivalirudin, in human plasma using nafarelin as internal
    standard (IS). Chromatographic separation was performed using a Shiseido MG3 mm column (2.0 × 50
    mm) with a gradient mobile phase consisting of water and acetonitrile containing 0.1 % formic acid at
    a flow rate of 0.4 mL/min, and total run time was within 5 min. Detection and quantification was
    performed by the mass spectrometer using a multiple reaction-monitoring mode at m/z 1091.0 → 650.3
    for bivalirudin, and m/z 662.1 → 249.3 for IS.
    Results: The assay was linear over a concentration range of 10 - 10000 ng/mL with a lower limit of
    quantification of 10 ng/mL in human plasma.
    Conclusion: This method was successfully applied for pharmacokinetics study after intravenous
    administration of bivalirudin to healthy Korean male volunteers.


    Bivalirudin, Liquid chromatography, Pharmacokinetics