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Methodology

Quantification of imatinib in human serum: validation of a high-performance liquid chromatography-mass spectrometry method for therapeutic drug monitoring and pharmacokinetic assays

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Pages 699-710 | Published online: 05 Aug 2013

References

  • Druker BJ Guilhot FO O’Brien SG IRIS Investigators Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia N Engl J Med 2006 355 23 2408 2417 17151364
  • Titier K Picard S Ducint D Quantification of imatinib in human plasma by high-performance liquid chromatography-tandem mass spectrometry Ther Drug Monit 2005 27 5 634 640 16175138
  • Kantarjian HM Talpaz M Imatinib mesylate: clinical results in Philadelphia chromosome-positive leukemias Semin Oncol 2001 28 5 Suppl 7 9 18 11740802
  • Guilhot F Hughes T Cortes J Plasma exposure of imatinib and its correlation with clinical response in the Tyrosine Kinase Inhibitor Optimization and Selectivity Trial Haematologica 2012 97 5 731 738 22315495
  • Awidi A Salem II Najib N Mefleh R Tarawneh B Determination of imatinib plasma levels in patients with chronic myeloid leukemia by high performance liquid chromatography-ultraviolet detection and liquid chromatography-tandem mass spectrometry: methods comparison Leuk Res 2010 34 6 714 717 19744707
  • Guilhot F Roy L Tomowiak C Current treatment strategies in chronic myeloid leukemia Curr Opin Hematol 2012 19 2 102 109 22227529
  • Parise RA Ramanathan RK Hayes MJ Egorin MJ Liquid chromatographic-mass spectrometric assay for quantitation of imatinib and its main metabolite (CGP 74588) in plasma J Chromatogr B Analyt Technol Biomed Life Sci 2003 791 1–2 39 44
  • Mičová K Friedecký D Faber E Polýnková A Adam T Flow injection analysis vs ultra high performance liquid chromatography coupled with tandem mass spectrometry for determination of imatinib in human plasma Clin Chim Acta 2010 411 23–24 1957 1962 20713033
  • Roth O Spreux-Varoquaux O Bouchet S 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 3–4 140 146 19853594
  • Davies A Hayes AK Knight K Watmough SJ Pirmohamed M Clark RE Simultaneous determination of nilotinib, imatinib and its main metabolite (CGP-74588) in human plasma by ultra-violet high performance liquid chromatography Leuk Res 2010 34 6 702 707 20004471
  • Solassol I Bressolle F Philibert L Charasson V Astre C Pinguet F Liquid chromatography-electrospray mass spectrometry determination of imatinib and its main metabolite, N-desmethyl-imatinib in human plasma J Liq Chromatogr Relat Technol 2006 29 2957 2974
  • Bakhtiar 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 6 1183 1194 12049982
  • Miura M Takahashi N Sawada KI Quantitative determination of imatinib in human plasma with high-performance liquid chromatography and ultraviolet detection J Chromatogr Sci 2011 49 5 412 415 21549035
  • US Food and Drug Administration Guidance for industry: bioanalytical method validation Rockville, MD Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2001 Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf Accessed June 6, 2013
  • ANVISA Resolution RE No. 899, of May 29, 2003. Brazil, Brazilian National Surveillance Agency (ANVISA); Diário Oficial da União 02/jun/2003 Available on line: http://www.in.gov.br/visualiza/index.jsp?jornal=1&pagina=56&data=02/06/2003 Accessed June 2, 2013
  • ANVISA Resolution RDC No. 27, of May 27, 2012. Brazil, Brazilian National Surveillance Agency (ANVISA); Diário Oficial da União 22/may/2012 Available from: http://www.in.gov.br/visualiza/index.jsp?data=22/05/2012&jornal=1&pagina=93&totalArquivos=192 Accessed June 2, 2013
  • Vessman J Stefan RI Staden JF Selectivity in analytical chemistry (IUPAC Recommendations 2001) Pure Appl Chem 2001 73 8 1381 1386
  • Hubert P Chiap P Crommen J The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington Conference to the laboratory Anal Chim Acta 1999 391 2 135 148
  • Matuszewski BK Constanzer ML Chavez-Eng CM Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS Anal Chem 2003 75 13 3019 3030 12964746
  • BIPM Joint Committee for Guides in Metrology (JCGM) Bureau of Weights and Measures (BIPM) International vocabulary of metrology — Basic and general concepts and associated terms (VIM) JCGM 200 2012 Joint Committee for Guides in Metrology, Bureau of Weights and Measures (BIPM) 2012 Available from: http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf Accessed June 2, 2013
  • Currie LA Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC Recommendations 1995) Pure Appl Chem 1995 67 10 1699 1723
  • Rezende VM Rivellis AJ Gomes MM Determination of serum imatinib mesylate in chronic myeloid leukemia patients: validation and application of a new analytical method to control therapy adherence Rev Bras Hematol Hemoter 2013 35 2 103 108 23741187
  • Annesley TM Ion suppression in mass spectrometry Clin Chem 2003 49 7 1041 1044 12816898
  • Cortes J Giles F O’Brien S Result of high-dose imatinib mesylate in patients with Philadelphia chromosome-positive chronic myeloid leukemia after failure of interferon-alpha Blood 2003 102 1 83 86 12637317
  • Cortes JE Baccarani M Guilhot FO Phase III, randomized, open-label study of daily imatinib mesylate 400 mg versus 800 mg in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase using molecular end points: tyrosine kinase inhibitor optimization and selectivity study J Clin Oncol 2010 28 3 424 430 20008622
  • Parrillo-Campiglia S Ercoli MC Umpierrez O Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers Clin Ther 2009 31 10 2224 2232 19922893
  • Larson RA Druker BJ Guilhot F Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study Blood 2008 111 8 4022 4028 18256322