Determination of nilotinib in spiked plasma, urine, and capsules by high-performance liquid chromatography with fluorimetric detection

• Autorzy: Yilmaz E. M. , Aydoğmuş Z. , Aboul-Enein H. Y.
• Języki publikacji: EN

Abstrakty

EN

A precise and sensitive reversed phase high-performance thin-layer chromatography (RP-HPLC) method was developed for the determination of nilotinib (NTB) in spiked plasma, urine, and pharmaceutical capsule formulation. The method was based on derivatization NTB with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in the borax buffer (pH 9). The method employs an isocratic elution using acetonitrile and 10 mM orthophosphoric acid (40:60 v/v) as a mobile phase and an C18 column (4.6 mm × 250 mm, 5 μm, Waters Symmetry), with a fluorescence detector (λex: 447 nm, λem: 530 nm). The method validation was performed with respect to linearity, recovery, accuracy, precision, and stability. The linear ranges were 100–600 ng mL−1 in standard solution, plasma, and urine. Correlation coefficients (r2) were higher than 0.9997 for all of the analytes, indicating good linear relationship. The percentage recovery was 87.89% for plasma, 95.35% for urine, and 96.07% for capsules.

Słowa kluczowe

EN

nilotinib; 4-chloro-7-nitrobenzofurazan; HPLC; plasma; urine; pharmaceutical analysis; stability studies

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2016
• Tom: Vol. 28, no. 3
• Strony: 313--331
• Opis fizyczny: Bibliogr. 19 poz., rys., tab.

Twórcy

autor

Yilmaz E. M.

• Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, 34116, Beyazıt, Istanbul, Turkey

autor

Aydoğmuş Z.

• Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, 34116, Beyazıt, Istanbul, Turkey

autor

Aboul-Enein H. Y.

Bibliografia

• [1] V. Gandhi, W. Plunkett, and J. E. Cortes, Clin. Cancer Res., 20, 1735 (2014)
• [2] C. Ustun and K. Natarajan, Clin Ther., 30, 1956 (2008)
• [3] Q. P. Ophelia, N. Gallagher, C. Tanaka, D. Fisher, V. Sethuraman, W. Zhou, T. H. Lin, D. Heuman, and H. Schran, Clin. Ther., 31, 2459 (2009)
• [4] M. Yuki, Y. Yamakawa, T. Uchida, T. Nambu, T. Kawaguchi, A. Hamada, and H. Saito, Biol. Pharm. Bull., 34, 1126 (2011)
• [5] G. Guetens, H. Prenen, G. De Boeck, A. vanOosterom, P. Schöffski, M. Highley, and E. A. de Brujin, J. Chromatogr. B, 846, 341 (2007)
• [6] S. Pursche, O. G. Ottomann, G. Ehninger, and E. Schleyer, J. Chromatogr. B, 852, 208 (2007)
• [7] R. A. Parise, M. J. Egorin, S. M. Christner, D. D. Shah, W. Zhou, and J. H. Beumer, J. Chromatogr. B, 877, 1894 (2009)
• [8] S. Bouchet, E. Chauzit, D. Ducint, N. Castaing, M. Canal Raffin, N. Moore, K. Titier, and M. Molimard, Clin. Chim. Acta, 412, 1060 (2011)
• [9] E. Pirro, S. De Francia, F. De Martino, C. Fava, S. Ulisciani, G. R. Cambrin, S. Racca, G. Saglio, and F. Di Carlo, J. Chromatogr. Sci., 49, 753 (2011)
• [10] A. Davies, A. K. Hayes, K. Knight, S. J. Watmough, M. Pirmohamed, and R. E. Clark Leukemia Res., 34, 702 (2010)
• [11] N. A. Lankheet, M. J. Hillebrand, H. Rosing, J. H. Schellens, J. H. Beijnen, and A. D. Huitema, Biomed. Chromatogr., 27, 466 (2013)
• [12] E. Kralj, J. Trontelj, T. Pajic, and A. Kristi J. Chromatogr. B, 903, 150 (2012)
• [13] L. Götze, A. Hegele, S. K. Metzelder, H. Renz, and W. A. Nockher, Clin. Chim. Acta, 413, 143 (2012)
• [14] A. Haouala, B. Zanolari, B. Rochat, M. Montemurro, K. Zaman, M. A. Duchosal, H. B. Ris, S. Leyvraz, N. Widmer, and L. A. Decosterd, J. Chromatogr. B, 877, 1982 (2009)
• [15] I. Andriamanana, I. Gana, B. Duretz, and A. Hulin, J. Chromatogr. B, 926, 83 (2013)
• [16] A. D’Avolio, M. Simiele, S. De Francia, A. Ariaudo, L. Baietto, J. Cusato, C. Fava, G. Saglio, F. Di Carlo, and G. Di Perri, J. Pharm. Biomed. Anal., 59, 109 (2012)
• [17] S. De Francia, A. D’Avolio, F. De Martino, E. Pirro, L. Bailetto, M. Siccardi, M. Simiele, S. Raccai, G. Saglio, F. Di Carlo, and G. Di Perri, J. Chromatogr. B, 877, 1721 (2009)
• [18] ICH Guidelines, Q1A (R2), Harmonised Tripartite Guideline, Stability Testing of New Drug Substances and Products (2003)
• [19] ICH Guidelines Q2(R1), Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology (2005)

Uwagi

PL

Opracowanie ze środków MNiSW w ramach umowy 812/P-DUN/2016 na działalność upowszechniającą naukę.