Key result
Novel LC-MS/MS assay accurately quantifies plasma bivalirudin down to 10 ng/mL for pharmacokinetic studies.
Why the study?
A sensitive and validated method for determining bivalirudin concentration in human plasma is needed to support pharmacokinetic studies.
A sensitive LC-MS/MS method was successfully developed and validated for measuring bivalirudin in human plasma, enabling pharmacokinetic studies.
Answers are grounded in this paper and cite their sources.
Supports detailed bivalirudin pharmacokinetic evaluation; extends bioanalytical options but leaves clinical adoption open.
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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Kim et al. (2013) studied Healthy. Bivalirudin was evaluated on Assay linearity and lower limit of quantification. A sensitive LC-MS/MS method for determining bivalirudin in human plasma was successfully developed, validated with a lower limit of quantification of 10 ng/mL, and applied to a pharmacokinetic study.
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