Development and validation of an high performance liquid chromatography-tandem mass spectrometry method for the determination of imatinib in rat tissues

Journal of Pharmaceutical and Biomedical Analysis

Volumn 73, Issue , 2013, Pages 103-107

  Bianchi, F ^a   Caffarri, E ^a   Cavalli, S ^a   Lagrasta, C ^a   Musci, M ^a   Quaini, F ^a   Savi, M ^a  

^a UNIVERSITY OF PARMA   (Italy)

Author keywords

Biological tissues; HPLC MS MS; Imatinib; Sample treatment; Validation

Indexed keywords

CARVEDILOL; IMATINIB;

ACCURACY; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DRUG DETERMINATION; DRUG LIVER LEVEL; DRUG TISSUE LEVEL; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIMIT OF QUANTITATION; MALE; NONHUMAN; PRIORITY JOURNAL; RAT; REPRODUCIBILITY; SOLVENT EXTRACTION; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS;

ANIMALS; ANTINEOPLASTIC AGENTS; BENZAMIDES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG MONITORING; LIMIT OF DETECTION; LIVER; MALE; MYOCARDIUM; PIPERAZINES; PYRIMIDINES; RATS; RATS, WISTAR; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; TANDEM MASS SPECTROMETRY; TISSUE DISTRIBUTION;

EID: 84869507974     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2012.05.034     Document Type: Article

References (31)

1. Capdeville R., Buchdunger E., Zimmerman J., Matte A. Glivec (STI571, imatinib), a rationally developed, targeted anticancer drug. Nat. Rev. Drug Discov. 2002, 1:493-502.
2. Druker B.J., Talpaz M., Resta D.J., Peng B., Buchdunger E., Ford J.M., Lyndon N.A., Kantarjian H., Capdeville R., Ohno-jones S., Sawyers C.L. 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. Deininger M., Buchdunger E., Druker B.J. The development of imatinib as a therapeutic agent for chronic myeloid leukaemia. Blood 2006, 105:2640-2653.
4. Demetri G.D., Von Mehren M., Blanke C.D., Van den Abbeele A.D., Eisenberg B., Roberts P.J., Heinrich M.C., Tuveson D.A., Singer S., Janicek M., Fletcher J.A., Silverman S.G., Silberman S.L., Capdeville R., Kiese B., Peng B., Dimitrijevic S., Druker B.J., Corless C., Fletcher C.D.M., Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N. Engl. J. Med. 2002, 347:472-480.
5. Dagher R., Cohen M., Williams G., Rothmann M., Gobburu J., Robbie G., Rahman A., Chen G., Staten A., Griebel D., Pazdur R. Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors. Clin. Cancer Res. 2002, 8:3034-3038.
6. D'Avolio A., Simiele M., De Francia S., Ariaudo A., Baietto L., Cusato J., Fava C., Saglio G., Di Carlo F., Di Perri G. HPLC-MS method for the simultaneous quantification of the antileukemia drugs imatinib, dasatinib and nilotinib in human peripheral blood mononuclear cell (PBMC). J. Pharm. Biomed. Anal. 2012, 59:109-116.
7. Teoh M., Narayanan P., Moo K.S., Radhakrisman S., Pillappan R., Bukhari N.I., Segarra I. HPLC determination of imatinib in plasma and tissues after multiple oral dose administration to mice. Pak. J. Pharm. Sci. 2010, 23:35-41.
8. Roth O., Spreux-Varoquaux O., Bouchet S., Rousselot P., Castaigne S., Rigardeau S., Raggueneau V., Therond P., Devillier P., Molimard M., Maneglier B. 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.
9. Hsieh Y., Galviz G., Zhou Q., Duncan C. Hydrophilic interaction liquid chromatography/tandem mass spectrometry for the simultaneous determination of dasatinib, imatinib and nilotinib in mouse plasma. Rapid Commun. Mass Spectrom. 2009, 23:1364-1370.
10. Rochat B., Fayet A., Widmer N., Lahrichi S.L., Pesse B., Décosterd L.A., Biollaz J. Imatinib metabolite profiling in parallel to imatinib quantification in plasma of treated patients using liquid chromatography-mass spectrometry. J. Mass Spectrom. 2008, 43:736-752.
11. Oostendorp R.L., Beijnen J.H., Schellens J.H.M., van Tellingen O. Determination of imatinib mesylate and its main metabolite (CGP74588) in human plasma and murine specimens by ion-pairing reversed-phase high-performance liquid chromatography. Biomed. Chromatogr. 2007, 21:747-754.
12. Velpandian T., Mathur R., Agarwal N.K., Arora B., Kumar L., Gupta S.K. Development and validation of a simple liquid chromatographic method with ultraviolet detection for the determination of imatinib in biological samples. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2004, 804:431-434.
13. Schleyer E., Pursche S., Köhne C.H., Schuler U., Renner U., Gschaidmeier H., Freiberg-Richter J., Leopold T., Jenke A., Bonin M., Bergemann T., le Coutre P., Gruner M., Bornhäuser M., Ottmann O.G., Ehninger G. Liquid chromatographic method for detection and quantitation of STI-571 and its main metabolite N-desmethyl-STI in plasma, urine, cerebrospinal fluid, culture medium and cell preparations. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2004, 799:23-36.
14. Parise R.A., Ramanathan R.K., Hayes M.J., Egorin M.J. Liquid chromatographic-mass spectrometric assay for quantitation of imatinib and its main metabolite (CGP 74588) in plasma. J. Chromatogr. A 2003, 791:39-44.
15. ®) in human plasma by solid-phase extraction-liquid chromatography-ultraviolet absorbance detection. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2004, 803:285-292.
16. Baktiar R., Khemani L., Hayes M., Bedman T., Tse F. Quantification of the anti-leukemia drug STI571 (Gleevec™) and its metabolite (CGP 74588) in monkey plasma using a semi-automated solid phase extraction procedure and liquid chromatography-tandem mass spectrometry. J. Pharm. Biomed. Anal. 2002, 28:1183-1194.
17. Neville K., Parise R.A., Thompson P., Aleksic A., Egorin M.J., Balis F.M., McGuffey L., McCully C., Berg S.L., Blaney S.M. Plasma and cerebrospinal fluid pharmacokinetics of imatinib after administration to nonhuman primates. Clin. Cancer Res. 2004, 10:2525-2529.
18. De Francia S., D'Avolio A., De Martino F., Pirro E., Baietto L., Siccardi M., simiele M., Racca S., Saglio G., di Carlo F., Di Perri G. New HPLC-MS method for the simultaneous quantification of the antileukemia drugs imatinib, dasatinib, and nilotinib in human plasma. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2009, 877:1721-1726.
19. ®) tumor tissue analysis by measurement of sediment and by liquid chromatography tandem mass spectrometry. J. Sep. Sci. 2006, 29:453-459.
20. Giles F.J., O'Dwyer M., Swords R. Class effects of tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia. Leukemia 2009, 23:1698-1707.
21. Tribelli M., Medeot M. Cardiotoxicity of imatinib: at the heart of the problem. Leuk. Res. 2011, 35:36-37.
22. Breccia M. Is imatinib-related cardiotoxicity still an open issue?. Leuk. Res. 2011, 35:34-35.
23. Kerkela R., Grazette L., Yacobi R., Iliescu C., Pattern R., Beahm C., Walters B., Shevtsov S., Pesant S., Clubb F.J., Rosenzweig A., Salomon R.N., Van Etten R.A., Alroy J., Durand J.-B., Force T. Cardiotoxicity of the cancer therapeutic agent imatinib mesylate. Nat. Med. 2006, 12:908-916.
24. Orphanos G.S., Ioannidi G.M., Ardavanis A.G. Cardiotoxicity induced by tyrosine kinase inhibitors. Acta Oncol. 2009, 48:964-970.
25. Wolf A., Couttet P., Dong M., Grenet O., Heron M., Junker U., Laengle U., Ledieu D., Marrer E., Nussher A., Persohn E., Pognan F., Rivière G.-J., Roth D.R., Trendelenburg C., Tsao J., Roman D. Imatinib does not induce cardiotoxicity at clinically relevant concentrations in preclinical studies. Leuk. Res. 2010, 34:1180-1188.
26. Ribeiro A.L., Soriano Marcolino M., Bittencourt H.N.S., Barbosa M.M., do Carmo M., Nunes P., Fonseca Xavier V., Clementino N.C.D. An evaluation of the cardiotoxicity of imatinib mesylate. Leuk. Res. 2008, 32:1809-1814.
27. Force T., Krause D.S., Van Etten R.A. Molecular mechanisms of cardiotoxicity of tyrosine kinase inhibition. Nat. Rev. Cancer 2007, 7:332-344.
28. Prezioso L., Galaverna F., Tanzi S., Frati C., Savi M., Lagrasta C., Cavalli S., Galati S., Ferraro F., Deangelis A., Piegari E., Rossi F., Rizzoli V., Quaini F. Imatinib mesylate induced cardiotoxicity: a cardiac progenitor cell disease?. Blood 2009, 114:866.
29. FDA Guidance for Industry, Bioanalytical Method Validation 2001, Center for Drug Evaluation and Research of the U. S. Department of Health and Human Services, Food and Drug Administration.
30. Jiang H., Zeng J., Zheng N., Kandoussi H., Pweng Q., Valentine J.L., Lange R.W., Arnold M.E. A convenient strategy for quantitative determination of drug concentrations in tissue homogenates using a liquid chromatography/tandem mass spectrometry assay for plasma samples. Anal. Chem. 2011, 83:6237-6244.
31. Ji Q.C., Zhang J., Rodila R., Watson P., El-Shourbagy T. Method development for the quantitation of ABT-578 in rabbit artery tissue by 96-well liquid-liquid extraction and liquid chromatography/tandem mass spectrometric detection. Rapid Commun. Mass Spectrom. 2004, 18:2293-2298.