Validation of LC-MS/MS Method for Determination of Bivalirudin in Human Plasma: Application to a Pharmacokinetic Study.
10.12793/jkscpt.2013.21.2.166
- Author:
Yo Han KIM
1
;
Hyun Jeong PARK
;
Hee Youn CHOI
;
Hyeong Seok LIM
;
Kyun Seop BAE
Author Information
1. Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, Seoul, Korea. ksbae@amc.seoul.kr
- Publication Type:Original Article
- Keywords:
Bivalirudin;
Liquid chromatography;
Pharmacokinetics
- MeSH:
Administration, Intravenous;
Angina, Unstable;
Chromatography, Liquid;
Humans*;
Male;
Mass Spectrometry;
Methods;
Nafarelin;
Percutaneous Coronary Intervention;
Pharmacokinetics;
Plasma*;
Thrombin;
Water
- From:Journal of Korean Society for Clinical Pharmacology and Therapeutics
2013;21(2):166-173
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
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 x 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.
