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KMID : 0391020130210020166
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2013 Volume.21 No. 2 p.166 ~ p.173
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Validation of LC-MS/MS Method for Determination of Bivalirudin in Human Plasma: Application to a Pharmacokinetic Study
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Kim Yo-Han
Park Hyun-Jeong
Choi Hee-Youn
Lim Hyeong-Seok
Bae Kyun-Seop
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Abstract
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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.
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KEYWORD
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Bivalirudin, Liquid chromatography, Pharmacokinetics
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