Simultaneous determination of nine tyrosine kinase inhibitors by 96-well solid-phase extraction and ultra performance LC/MS-MS

Clinica Chimica Acta

Volumn 412, Issue 11-12, 2011, Pages 1060-1067

  Bouchet, Stéphane ^a   Chauzit, Emmanuelle ^a   Ducint, Dominique ^a   Castaing, Nadège ^a   Canal Raffin, Mireille ^a   Moore, Nicholas ^a   Titier, Karine ^a   Molimard, Mathieu ^a  

^a HÔPITAL PELLEGRIN   (France)

Author keywords

Imatinib; Mass spectrometry; Nilotinib; TDM (therapeutic drug monitoring); Tyrosine kinase inhibitors; UPLC

Indexed keywords

ACETONITRILE; AMMONIUM FORMATE; AXITINIB; DASATINIB; ERLOTINIB; GEFITINIB; IMATINIB; LAPATINIB; NILOTINIB; PROTEIN TYROSINE KINASE INHIBITOR; SORAFENIB; SUNITINIB;

ACCURACY; ARTICLE; CONTROLLED STUDY; DENSITY GRADIENT; DRUG DETERMINATION; DRUG MONITORING; DRUG STABILITY; ELECTROSPRAY; HUMAN; INTERMETHOD COMPARISON; MASS SPECTROMETRY; PHASE TRANSITION; PRIORITY JOURNAL; PROCESS DEVELOPMENT; SENSITIVITY AND SPECIFICITY; SOLID PHASE EXTRACTION; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; VALIDATION PROCESS;

BLOOD CHEMICAL ANALYSIS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; LINEAR MODELS; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; REFERENCE STANDARDS; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; TIME FACTORS;

EID: 79955036989     PISSN: 00098981     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cca.2011.02.023     Document Type: Article

References (42)

1. Karaman M.W., Herrgard S., Treiber D.K., et al. A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol 2008, 26:127-132.
2. Druker B.J., Talpaz M., Resta D.J., et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 2001, 344:1031-1037.
3. Shah N.P., Tran C., Lee F.Y., Chen P., Norris D., Sawyers C.L. Overriding imatinib resistance with a novel ABL kinase inhibitor. Science 2004, 305:399-401.
4. Golemovic M., Verstovsek S., Giles F., et al. AMN107, a novel aminopyrimidine inhibitor of Bcr-Abl, has in vitro activity against imatinib-resistant chronic myeloid leukemia. Clin Cancer Res 2005, 11:4941-4947.
5. Mauro M.J., Deininger M.W. Chronic myeloid leukemia in 2006: a perspective. Haematologica 2006, 91:152.
6. Weisberg E., Wright R.D., Jiang J., et al. Effects of PKC412, nilotinib, and imatinib against GIST-associated PDGFRA mutants with differential imatinib sensitivity. Gastroenterology 2006, 131:1734-1742.
7. Joensuu H. Sunitinib for imatinib-resistant GIST. Lancet 2006, 368:1303-1304.
8. Rusnak D.W., Affleck K., Cockerill S.G., et al. The characterization of novel, dual ErbB-2/EGFR, tyrosine kinase inhibitors: potential therapy for cancer. Cancer Res 2001, 61:7196-7203.
9. Hainsworth J.D., Sosman J.A., Spigel D.R., Edwards D.L., Baughman C., Greco A. Treatment of metastatic renal cell carcinoma with a combination of bevacizumab and erlotinib. J Clin Oncol 2005, 23:7889-7896.
10. Bonomi P. Erlotinib: a new therapeutic approach for non-small cell lung cancer. Expert Opin Investig Drugs 2003, 12:1395-1401.
11. Baselga J., Averbuch S.D. ZD1839 ('Iressa') as an anticancer agent. Drugs 2000, 60(Suppl. 1):33-40. (discussion 41-32).
12. Faivre S., Delbaldo C., Vera K., et al. Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 2006, 24:25-35.
13. Gollob J.A. Sorafenib: scientific rationales for single-agent and combination therapy in clear-cell renal cell carcinoma. Clin Genitourin Cancer 2005, 4:167-174.
14. Kelly R.J., Rixe O. Axitinib-a selective inhibitor of the vascular endothelial growth factor (VEGF) receptor. Target Oncol 2009, 4:297-305.
15. Picard S., Titier K., Etienne G., et al. Trough imatinib plasma levels are associated with both cytogenetic and molecular responses to standard-dose imatinib in chronic myeloid leukemia. Blood 2007, 109(8):3496-3499.
16. Schmidli H., Peng B., Riviere G.J., et al. Population pharmacokinetics of imatinib mesylate in patients with chronic-phase chronic myeloid leukaemia: results of a phase III study. Br J Clin Pharmacol 2005, 60:35-44.
17. Von Mehren M., Reichardt P., Casali P.G., et al. A phase I study of nilotinib alone and in combination with imatinib (IM) in patients (pts) with imatinib-resistant gastrointestinal stromal tumors (GIST) - study update. ASCO Meeting Abstracts 2007, 25. 10023.
18. Ryan C.W., Curti B.D., Pattee K.J., Besaw L., Beer T.M., B.F. A dose-escalation phase II study of sunitinib (S) plus erlotinib (E) in advanced renal carcinoma (RCC). Genitourinary Cancers Symposium 2008.
19. Weisberg E., Catley L., Wright R.D., et al. Beneficial effects of combining nilotinib and imatinib in preclinical models of BCR-ABL+ leukemias. Blood 2007, 109:2112-2120.
20. Blanchet B., Billemont B., Cramard J., et al. Validation of an HPLC-UV method for sorafenib determination in human plasma and application to cancer patients in routine clinical practice. J Pharm Biomed Anal 2009, 49:1109-1114.
21. Pursche S., Ottmann O.G., Ehninger G., Schleyer E. High-performance liquid chromatography method with ultraviolet detection for the quantification of the BCR-ABL inhibitor nilotinib (AMN107) in plasma, urine, culture medium and cell preparations. J Chromatogr B Analyt Technol Biomed Life Sci 2007, 852:208-216.
22. Zhang W., Siu L.L., Moore M.J., Chen E.X. Simultaneous determination of OSI-774 and its major metabolite OSI-420 in human plasma by using HPLC with UV detection. J Chromatogr B Analyt Technol Biomed Life Sci 2005, 814:143-147.
23. Bai F., Freeman B.B., Fraga C.H., Fouladi M., Stewart C.F. Determination of lapatinib (GW572016) in human plasma by liquid chromatography electrospray tandem mass spectrometry (LC-ESI-MS/MS). J Chromatogr B Analyt Technol Biomed Life Sci 2006, 831:169-175.
24. Minkin P., Zhao M., Chen Z., Ouwerkerk J., Gelderblom H., Baker S.D. Quantification of sunitinib in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2008, 874:84-88.
25. Sparidans R.W., Vlaming M.L., Lagas J.S., Schinkel A.H., Schellens J.H., Beijnen J.H. Liquid chromatography-tandem mass spectrometric assay for sorafenib and sorafenib-glucuronide in mouse plasma and liver homogenate and identification of the glucuronide metabolite. J Chromatogr B Analyt Technol Biomed Life Sci 2009, 877:269-276.
26. Titier K., Picard S., Ducint D., et al. Quantification of imatinib in human plasma by high-performance liquid chromatography-tandem mass spectrometry. Ther Drug Monit 2005, 27:634-640.
27. Jones H.K., Stafford L.E., Swaisland H.C., Payne R. A sensitive assay for ZD1839 (Iressa) in human plasma by liquid-liquid extraction and high performance liquid chromatography with mass spectrometric detection: validation and use in Phase I clinical trials. J Pharm Biomed Anal 2002, 29:221-228.
28. De Francia S., D'Avolio A., De Martino F., et al. New HPLC-MS method for the simultaneous quantification of the antileukemia drugs imatinib, dasatinib, and nilotinib in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2009, 877:1721-1726.
29. Honeywell R., Yarzadah K., Giovannetti E., et al. Simple and selective method for the determination of various tyrosine kinase inhibitors used in the clinical setting by liquid chromatography tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2010, 878:1059-1068.
30. Haouala A., Zanolari B., Rochat B., et al. Therapeutic drug monitoring of the new targeted anticancer agents imatinib, nilotinib, dasatinib, sunitinib, sorafenib and lapatinib by LC tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2009, 877:1982-1996.
31. Churchwell M.I., Twaddle N.C., Meeker L.R., Doerge D.R. Improving LC-MS sensitivity through increases in chromatographic performance: comparisons of UPLC-ES/MS/MS to HPLC-ES/MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci 2005, 825:134-143.
32. Sherma J. UPLC: ultra-performance liquid chromatography. J AOAC Int 2005, 88:63A-67A.
33. Annesley T.M. Ion suppression in mass spectrometry. Clin Chem 2003, 49:1041-1044.
34. Taylor P.J. Matrix effects: the Achilles heel of quantitative high-performance liquid chromatography-electrospray-tandem mass spectrometry. Clin Biochem 2005, 38:328-334.
35. Rugo H.S., Herbst R.S., Liu G., et al. Phase I trial of the oral antiangiogenesis agent AG-013736 in patients with advanced solid tumors: pharmacokinetic and clinical results. J Clin Oncol 2005, 23:5474-5483.
36. Center for Drug Evaluation and Research Guidance for industry: bioanalytical method validation 2001.
37. Guideline on validation of bioanalytical methods 2009, Committee for Medicinal Products for Human Use (CHMP).
38. Bressolle F., Bromet-Petit M., Audran M. Validation of liquid chromatographic and gas chromatographic methods. Applications to pharmacokinetics. J Chromatogr B Biomed Sci Appl 1996, 686:3-10.
39. Causon R. Validation of chromatographic methods in biomedical analysis. Viewpoint and discussion. J Chromatogr B Biomed Sci Appl 1997, 689:175-180.
40. Roth O., Spreux-Varoquaux O., Bouchet S., et al. Imatinib assay by HPLC with photodiode-array UV detection in plasma from patients with chronic myeloid leukemia: comparison with LC-MS/MS. Clin Chim Acta 2010, 411:140-146.
41. Chambers E., Wagrowski-Diehl D.M., Lu Z., Mazzeo J.R. Systematic and comprehensive strategy for reducing matrix effects in LC/MS/MS analyses. J Chromatogr B Analyt Technol Biomed Life Sci 2007, 852:22-34.
42. Shah N.P., Kantarjian H.M., Kim D.-W., et al. Intermittent target inhibition with dasatinib 100mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol 2008, 26:3204-3212.