An HPLC–PDA method for determination of alectinib concentrations in the plasma of an adolescent

• Autorzy: Lee Samiuela , Nath Christa E. , Balzer Ben W. R. , Lewis Craig R. , Trahair Toby N. , Anazodo Antoinette C. , Shaw Peter J.

Identyfikatory

DOI

10.1556/1326.2019.00578

• Języki publikacji: EN

Abstrakty

EN

Alectinib is a central nervous system-active small molecule anaplastic lymphoma kinase (ALK) inhibitor that is effective in the treatment of patients with ALK positive tumors, including advanced non-small cell lung cancers and lymphomas. A simple, isocratic high-performance liquid chromatography–photo diode array detection (HPLC–PDA) assay for measurement of alectinib in human plasma is described. Alectinib is extracted from the plasma matrix by addition of methanol, followed by centrifugation and acidification with 0.1% formic acid. It elutes with a run time of 4.6 min using a 250 mm × 4.6 mm RP-C18 column with 0.1% aqueous formic acid and methanol (35:65, v/v) and a flow rate of 1 mL/min. Detection was at 339 nm. Linear calibration plots were achieved in the range of 0.1–20 μg/mL for alectinib (r2 = 0.9996). With limits of detection and quantification of 0.05 and 0.1 μg/mL, respectively, and excellent precision (%CV < 10%), accuracy (bias < ±12%), and recovery (>97%) within the 1–20 μg/mL concentration range, this assay was suitable for measuring pre-dose alectinib concentrations in an adolescent receiving 600-mg doses twice daily.

Słowa kluczowe

EN

HPLC-PDA; alectinib; human plasma

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2020
• Tom: Vol. 32, no. 3
• Strony: 166--169
• Opis fizyczny: Bibliogr. 8 poz., rys., tab.

Twórcy

autor

Lee Samiuela

• The Children’s Hospital at Westmead, Australia
• University of Sydney, Australia

autor

Nath Christa E.

• University of Sydney, Australia

autor

Balzer Ben W. R.

• Sydney Children's Hospital, Randwick NSW 2031, Australia
• University of New South Wales, Randwick NSW 2031, Australia

autor

Lewis Craig R.

• Nelune Comprehensive Cancer Centre, Prince of Wales Hospital, Randwick NSW 2031, Australia
• University of New South Wales, Randwick NSW 2031, Australia

autor

Trahair Toby N.

• University of New South Wales, Randwick NSW 2031, Australia
• Kids Cancer Centre, Sydney Children's Hospital, Randwick NSW 2031, Australia

autor

Anazodo Antoinette C.

• University of New South Wales, Randwick NSW 2031, Australia
• Nelune Comprehensive Cancer Centre, Prince of Wales Hospital, Randwick NSW 2031, Australia
• Kids Cancer Centre, Sydney Children's Hospital, Randwick NSW 2031, Australia

autor

Shaw Peter J.

• Cancer Centre for Children, The Children's Hospital at Westmead, Australia
• University of Sydney, Australia

Bibliografia

• [1] Camidge, P. S.; Shaw, A. T.; Gadgeel, S.; Ahn, J. S.; Kim, D. W.; Ou, S. I.; Pérol, M.; Dziadziuszko, R.; Rosell, R.; Zeaiter, A.; Mitry, E.; Golding, S.; Balas, B.; Noe, J.; Morcos, P. N.; Mok, T. N. Engl. J. Med. 2017, 377, 829.
• [2] Gadgeel, S. M.; Gandhi, L.; Riely, G. J.; Chiappori, A. A.; West, H. L.; Azada, M. C.; Morcos, P. N.; Lee, R.; Garcia, L.; Yu, L.; Boisserie, F.; Di Laurenzio, L.; Golding, S.; Sato, J.; Yokoyama, S.; Tanaka, T.; Ou, S. I. Lancet 2014, 15, 1119.
• [3] Hsu, J. C.; Carnac, R.; Henschel, V.; Bogman, K.; Martin-Facklam, M.; Guerini, E.; Balas, B.; Zeaiter, A. H.; Phipps, A.; Morcos, P. N.; Frey, N. J. Clin. Oncol. 2016, 34, abstract e20598.
• [4] Morcos, P. N.; Nueesch, E.; Jaminion, F.; Guerini, E.; Hsu, J. C.; Bordogna, W.; Balas, B.; Mercier, F. Cancer Chemother. Pharmacol. 2018, 82, 129.
• [5] Huang, X.-X.; Li, Y.-X.; Li, X.-Y.; Hu, X.-X.; Tang, P.-F.; Hu, G.-X. J. Pharm. Biomed. Anal. 2017, 132, 227.
• [6] Srikanth, I.; Prameela, R. A. Int. J. Curr. Res. 2017, 9, 51506.
• [7] European Medicines Agency. Guideline on Bioanalytical Method Validation. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf (Accessed: October 2018)
• [8] Sato-Nakai, M.; Kawashima, K.; Nakagawa, T.; Tachibana, Y.; Yoshida, M.; Takanashi, K.; Morcos, P. N.; Binder, M.; Moore, D. J.; Yu, L. Heliyon 2017, 3, e00354.

Uwagi

PL

Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2020).