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Journal of Analytical Methods in Chemistry
Volume 2015, Article ID 215128, 6 pages
http://dx.doi.org/10.1155/2015/215128
Research Article

Ultra High Performance Liquid Chromatography Method for the Determination of Two Recently FDA Approved TKIs in Human Plasma Using Diode Array Detection

1Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo 11562, Egypt
2Laboratory of Pharmaceutical Analysis, Faculty of Medicine and Pharmacy, Research Institute for Health Sciences and Technology, University of Mons (UMONS), Place du Parc 20, 7000 Mons, Belgium

Received 1 March 2015; Accepted 20 April 2015

Academic Editor: Mohamed Abdel-Rehim

Copyright © 2015 Marwa Fouad et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. D. S. Krause and R. A. van Etten, “Tyrosine kinases as targets for cancer therapy,” The New England Journal of Medicine, vol. 353, pp. 172–187, 2005. View at Publisher · View at Google Scholar
  2. T. E. Hutson, I. D. Davis, J.-P. H. Machiels et al., “Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma,” Journal of Clinical Oncology, vol. 28, no. 3, pp. 475–480, 2010. View at Publisher · View at Google Scholar · View at Scopus
  3. G. D. Demetri, A. T. van Oosterom, C. R. Garrett et al., “Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial,” The Lancet, vol. 368, no. 9544, pp. 1329–1338, 2006. View at Publisher · View at Google Scholar · View at Scopus
  4. B. J. Druker, M. Talpaz, D. J. Resta et al., “Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia,” The New England Journal of Medicine, vol. 344, no. 14, pp. 1031–1037, 2001. View at Publisher · View at Google Scholar · View at Scopus
  5. T. E. Hutson, J. Bellmunt, C. Porta et al., “Long-term safety of sorafenib in advanced renal cell carcinoma: follow-up of patients from phase III TARGET,” European Journal of Cancer, vol. 46, no. 13, pp. 2432–2440, 2010. View at Publisher · View at Google Scholar · View at Scopus
  6. N. P. van Erp, S. D. Baker, A. S. Zandvliet et al., “Marginal increase of sunitinib exposure by grapefruit juice,” Cancer Chemotherapy and Pharmacology, vol. 67, no. 3, pp. 695–703, 2011. View at Publisher · View at Google Scholar · View at Scopus
  7. A. Broniscer, S. J. Baker, C. F. Stewart et al., “Phase Ii and Pharmacokinetic studies of erlotinib administered concurrently with radiotherapy for children, adolescents, and young adults with high-grade glioma,” Clinical Cancer Research, vol. 15, no. 2, pp. 701–707, 2009. View at Publisher · View at Google Scholar · View at Scopus
  8. S. Bouchet, E. Chauzit, D. Ducint et al., “Simultaneous determination of nine tyrosine kinase inhibitors by 96-well solid-phase extraction and ultra performance LC/MS-MS,” Clinica Chimica Acta, vol. 412, no. 11-12, pp. 1060–1067, 2011. View at Publisher · View at Google Scholar · View at Scopus
  9. G. D. Demetri, P. G. Casali, J.-Y. Blay et al., “A phase I study of single-agent nilotinib or in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors,” Clinical Cancer Research, vol. 15, no. 18, pp. 5910–5916, 2009. View at Publisher · View at Google Scholar · View at Scopus
  10. H. I. Hurwitz, A. Dowlati, S. Saini et al., “Phase I trial of pazopanib in patients with advanced cancer,” Clinical Cancer Research, vol. 15, no. 12, pp. 4220–4227, 2009. View at Publisher · View at Google Scholar · View at Scopus
  11. J. F. T. Teng, V. H. Mabasa, and M. H. H. Ensom, “The role of therapeutic drug monitoring of imatinib in patients with chronic myeloid leukemia and metastatic or unresectable gastrointestinal stromal tumors,” Therapeutic Drug Monitoring, vol. 34, no. 1, pp. 85–97, 2012. View at Publisher · View at Google Scholar · View at Scopus
  12. M. E. De Jonge, A. D. R. Huitema, J. H. M. Schellens, S. Rodenhuis, and J. H. Beijnen, “Individualised cancer chemotherapy: strategies and performance of prospective studies on therapeutic drug monitoring with dose adaptation: a review,” Clinical Pharmacokinetics, vol. 44, no. 2, pp. 147–173, 2005. View at Publisher · View at Google Scholar · View at Scopus
  13. S. Picard, K. Titier, G. Etienne et al., “Trough imatinib plasma levels are associated with both cytogenetic and molecular responses to standard-dose imatinib in chronic myeloid leukemia,” Blood, vol. 109, no. 8, pp. 3496–3499, 2007. View at Publisher · View at Google Scholar · View at Scopus
  14. D. Li, L. Ambrogio, T. Shimamura et al., “BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models,” Oncogene, vol. 27, no. 34, pp. 4702–4711, 2008. View at Publisher · View at Google Scholar · View at Scopus
  15. R. Bahleda, J. Soria, Y. Berge et al., “Phase I trial assessing safety and pharmacokinetics of afatinib (BIBW 2992) with intravenous weekly vinorelbine in advanced solid tumors,” Journal of Clinical Oncology, vol. 29, no. 15, supplement, p. 2585, 2011. View at Google Scholar
  16. F. Solca, G. Dahl, A. Zoephel et al., “Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker,” Journal of Pharmacology and Experimental Therapeutics, vol. 343, no. 2, pp. 342–350, 2012. View at Publisher · View at Google Scholar · View at Scopus
  17. V. A. Miller, V. Hirsh, J. Cadranel et al., “Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial,” The Lancet Oncology, vol. 13, no. 5, pp. 528–538, 2012. View at Publisher · View at Google Scholar · View at Scopus
  18. J. C. H. Yang, J. Y. Shih, W. C. Su et al., “Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial,” The Lancet Oncology, vol. 13, no. 5, pp. 539–548, 2012. View at Publisher · View at Google Scholar · View at Scopus
  19. L. V. Sequist, J. C.-H. Yang, N. Yamamoto et al., “Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations,” Journal of Clinical Oncology, vol. 31, no. 27, pp. 3327–3334, 2013. View at Publisher · View at Google Scholar · View at Scopus
  20. Y.-L. Wu, C. Zhou, C.-P. Hu et al., “Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial,” The Lancet Oncology, vol. 15, no. 2, pp. 213–222, 2014. View at Publisher · View at Google Scholar · View at Scopus
  21. T. Y. Seiwert, J. Fayette, D. Cupissol et al., “A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck,” Annals of Oncology, vol. 25, no. 9, pp. 1813–1820, 2014. View at Publisher · View at Google Scholar
  22. S. Cheng, J. Ma, A. Guo et al., “BTK inhibition targets in vivo CLL proliferation through its effects on B-cell receptor signaling activity,” Leukemia, vol. 28, no. 3, pp. 649–657, 2013. View at Publisher · View at Google Scholar
  23. L. A. Honigberg, A. M. Smith, M. Sirisawad et al., “The Bruton tyrosine kinase inhibitor PCI-32765 blocks B-cell activation and is efficacious in models of autoimmune disease and B-cell malignancy,” Proceedings of the National Academy of Sciences of the United States of America, vol. 107, no. 29, pp. 13075–13080, 2010. View at Publisher · View at Google Scholar · View at Scopus
  24. D. Wodarz, N. Garg, N. L. Komarova et al., “Kinetics of CLL cells in tissues and blood during therapy with the BTK inhibitor ibrutinib,” Blood, vol. 123, no. 26, pp. 4132–4135, 2014. View at Publisher · View at Google Scholar
  25. J. R. Brown, “Ibrutinib (PCI-32765), the first BTK (Bruton's tyrosine kinase) inhibitor in clinical trials,” Current Hematologic Malignancy Reports, vol. 8, no. 1, pp. 1–6, 2013. View at Publisher · View at Google Scholar · View at Scopus
  26. P. Stopfer, K. Marzin, H. Narjes et al., “Afatinib pharmacokinetics and metabolism after oral administration to healthy male volunteers,” Cancer Chemotherapy and Pharmacology, vol. 69, no. 4, pp. 1051–1061, 2012. View at Publisher · View at Google Scholar · View at Scopus
  27. Food and Drug Administration, Afatinib @ Approved Drugs, Food and Drug Administration, 2013, http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm360574.htm.
  28. Food and Drug Administration, Ibrutinib @ Approved Drugs, FDA, 2013, http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm374857.htm.
  29. Food and Drug Administration, Ibrutinib @ Approved Drugs, FDA, 2014, http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm385878.htm.
  30. C. Bardin, G. Veal, A. Paci et al., “Therapeutic drug monitoring in cancer—are we missing a trick?” European Journal of Cancer, vol. 50, pp. 2020–2036, 2014. View at Google Scholar · View at Scopus
  31. P. Hubert, J.-J. Nguyen-Huu, B. Boulanger et al., “Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal—part I,” Journal of Pharmaceutical and Biomedical Analysis, vol. 36, no. 3, pp. 579–586, 2004. View at Publisher · View at Google Scholar · View at Scopus
  32. P. Hubert, J.-J. Nguyen-Huu, B. Boulanger et al., “Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal—part II,” Journal of Pharmaceutical and Biomedical Analysis, vol. 45, no. 1, pp. 70–81, 2007. View at Publisher · View at Google Scholar · View at Scopus
  33. P. Hubert, J.-J. Nguyen-Huu, B. Boulanger et al., “Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal-Part III,” Journal of Pharmaceutical and Biomedical Analysis, vol. 45, no. 1, pp. 82–96, 2007. View at Publisher · View at Google Scholar · View at Scopus
  34. S. Hambÿe, D. Stanicki, J.-M. Colet, E. M. Aliouat, J. J. Vanden Eynde, and B. Blankert, “Three optimized and validated (using accuracy profiles) LC methods for the determination of pentamidine and new analogs in rat plasma,” Talanta, vol. 83, no. 3, pp. 832–839, 2011. View at Publisher · View at Google Scholar · View at Scopus
  35. D. H. Shewiyo, E. Kaale, P. G. Risha et al., “Accuracy profiles assessing the validity for routine use of high-performance thin-layer chromatographic assays for drug formulations,” Journal of Chromatography A, vol. 1293, pp. 159–169, 2013. View at Publisher · View at Google Scholar · View at Scopus
  36. J. M. Mermet and G. Granier, “Potential of accuracy profile for method validation in inductively coupled plasma spectrochemistry,” Spectrochimica Acta, Part B Atomic Spectroscopy, vol. 76, pp. 214–220, 2012. View at Publisher · View at Google Scholar · View at Scopus
  37. G. Mercier and C. Campargue, “Partially hydrolyzed guar gum characterization and sensitive quantification in food matrices by high performance anion exchange chromatography with pulsed amperometric detection-validation using accuracy profile,” Journal of Chromatography A, vol. 1262, pp. 180–187, 2012. View at Publisher · View at Google Scholar · View at Scopus
  38. V. Varlet, F. Smith, and M. Augsburger, “Accuracy profile validation of a new analytical method for butane measurement using headspace-gas chromatography-mass spectrometry,” Journal of Chromatography B, vol. 913-914, pp. 155–160, 2013. View at Publisher · View at Google Scholar · View at Scopus
  39. V. Varlet, E. L. de Croutte, M. Augsburger, and P. Mangin, “Accuracy profile validation of a new method for carbon monoxide measurement in the human blood using headspace-gas chromatography-mass spectrometry (HS-GC-MS),” Journal of Chromatography B, vol. 880, no. 1, pp. 125–131, 2012. View at Publisher · View at Google Scholar · View at Scopus
  40. M. Helvenstein, S. Hambye, and B. Blankert, “Determination of three tyrosine kinase inhibitors and one active metabolite by an identical and validated ultra-performance liquid chromatography-DAD method in human plasma,” Current Pharmaceutical Analysis, vol. 10, no. 3, pp. 161–168, 2014. View at Publisher · View at Google Scholar