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Rapid Determination of Imatinib in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry: Application to a Pharmacokinetic Study

  • Yang, Jeong Soo (Clinical Trial Center, Clinical Research Institute, Samsung Medical Center) ;
  • Cho, Eun Gi (Clinical Trial Center, Samsung Medical Center) ;
  • Huh, Wooseong (Department of Medicine and Department of Clinical Pharmacology, Samsung Medical Center, Sungkyunkwan University) ;
  • Ko, Jae-Wook (Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center) ;
  • Jung, Jin Ah (Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center) ;
  • Lee, Soo-Youn (Department of Laboratory Medicine and Genetics and Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Sungkyunkwan University School of Medicine)
  • Received : 2013.03.30
  • Accepted : 2013.05.21
  • Published : 2013.08.20

Abstract

A simple, fast and robust analytical method was developed to determine imatinib in human plasma using liquid chromatography-tandem mass spectrometry with electrospray ionization in the positive ion mode. Imatinib and labeled internal standard were extracted from plasma with a simple protein precipitation. The chromatographic separation was performed using an isocratic elution of mobile phase involving 5.0 mM ammonium formate in water-5.0 mM ammonium formate in methanol (30:70, v/v) over 3.0 min on reversed-stationary phase. The detection was performed using a triple-quadrupole tandem mass spectrometer in multiple-reaction monitoring mode. The developed method was validated with lower limit of quantification of 10 ng/mL. The calibration curve was linear over 10-2000 ng/mL ($R^2$ > 0.99). The method validation parameters met the acceptance criteria. The spiked samples and standard solutions were stable under conditions for storage and handling. The reliable method was successfully applied to real sample analyses and thus a pharmacokinetic study in 27 healthy Korean male volunteers.

Keywords

References

  1. Ramakrishna, K.; Raman, N. V.; Rao, K. M.; Prasad, A. V.; Reddy, K. S. J. Pharm. Biomed. Anal. 2008, 46(4), 780. https://doi.org/10.1016/j.jpba.2007.11.013
  2. Bianchi, F.; Caffarri, E.; Cavalli, S.; Lagrasta, C.; Musci, M.; Quaini, F.; Savi, M. J. Pharm. Biomed. Anal. 2013, 73, 103. https://doi.org/10.1016/j.jpba.2012.05.034
  3. Lankheet, N. A.; Hillebrand, M. J.; Rosing, H.; Schellens, J. H.; Beijnen, J. H.; Huitema, A. D. Biomed. Chromatogr. 2012, DOI:10.1002/bmc.2814.
  4. Couchman, L.; Birch, M.; Ireland, R.; Corrigan, A.; Wickramasinghe, S.; Josephs, D.; Spicer, J.; Flanagan, R. J. Anal. Bioanal. Chem. 2012, 403(6), 1685. https://doi.org/10.1007/s00216-012-5970-2
  5. Gotze, L.; Hegele, A.; Metzelder, S. K.; Renz, H.; Nockher, W. A. Clin. Chim. Acta 2012, 413(1-2), 143. https://doi.org/10.1016/j.cca.2011.09.012
  6. Iqbal, Z.; Elliott, M.; Watson, D. G.; Holyoake, T.; Jorgensen, H. Pak. J. Pharm. Sci. 2011, 24(3), 285.
  7. Chahbouni, A.; den Burger, J. C.; Vos, R. M.; Sinjewel, A.; Wilhelm, A. J. Ther. Drug Monit. 2009, 31(6), 683.
  8. Awidi, A.; Salem, I. I.; Najib, N.; Mefleh, R.; Tarawneh, B. Leuk. Res. 2010, 34(6), 714. https://doi.org/10.1016/j.leukres.2009.08.005
  9. Hsieh, Y.; Galviz, G.; Zhou, Q.; Duncan, C. Rapid. Commun. Mass Spectrom. 2009, 23(9), 1364. https://doi.org/10.1002/rcm.4010
  10. Rochat, B.; Fayet, A.; Widmer, N.; Lahrichi, S. L.; Pesse, B.; Décosterd, L. A.; Biollaz, J. J. Mass Spec. 2008, 43(6), 736. https://doi.org/10.1002/jms.1369
  11. Bakhtiar, R.; Khemani, L.; Hayes, M.; Bedman, T.; Tse, F. J. Pharm. Biomed. Anal. 2002, 28(6), 1183. https://doi.org/10.1016/S0731-7085(02)00080-8
  12. Bakhtiar, R.; Lohne, J.; Ramos, L.; Khemani, L.; Hayes, M.; Tse, F. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2002, 768(2), 325. https://doi.org/10.1016/S1570-0232(01)00611-0
  13. US Food and Drug Administration, Guidance for Industry: Bioanalytical Method Validation, Centre for Drug Evaluation and Research, Rockville, MD (2001), http://www.fda.gov/cder/ guidance/4252fnl.pdf
  14. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 2008, World Medical Association. http://www.wma.net/en/30publications/10policies/b3/. Accessed 20 Feb 2013.
  15. Peng, B.; Hayes, M.; Resta, D.; Racine-Poon, A.; Druker, B. J.; Talpaz, M.; Sawyers, C. L.; Rosamilia, M.; Ford, J.; Lloyd, P.; Capdeville, R. J. Clin. Oncol. 2004, 22(5), 935. https://doi.org/10.1200/JCO.2004.03.050
  16. Dutreix, C.; Peng, B.; Mehring, G.; Hayes, M.; Capdeville, R.; Pokorny, R.; Seiberling, M. Cancer Chemother. Pharmacol. 2004, 54(4), 290.
  17. Schmidli, H.; Peng, B.; Riviere, G. J.; Capdeville, R.; Hensley, M.; Gathmann, I.; Bolton, A. E.; Racine-Poon, A. Br. J. Clin. Pharmacol. 2005, 60(1), 35. https://doi.org/10.1111/j.1365-2125.2005.02372.x
  18. Leveque, D.; Maloisel, F. In Vivo 2005, 19(1), 77.