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Development and Validation of Novel HPLC Bioanalytical Analysis Method for Acalabrutinib: An Anticancer Drug in Human Plasma
Corresponding Author(s) : G. Atchutarama Krishna
Asian Journal of Chemistry,
Vol. 32 No. 10 (2020): Vol 32 Issue 10
Abstract
The aim of the work is to develop and validate the bioanalytical RP-HPLC method for determination of acalabrutinib in plasma with nifedipine drug as internal standard. Liquid-liquid extraction with diethyl ether and methanol in the ratio of 50:50 (v/v) was used for the extraction of drugs from the biological matrix. The optimized chromatography conditions consist of methanol, acetonitrile and 0.1% orthophosphoric acid in the ratio of 45:35:20 (v/v) as a mobile phase with KNAUER Eurospher II C18 Column (250 × 4.6 mm, 5μ) as stationary phase. Isocratic elution with 0.9 mL flow separates acalabrutinib at 4.6 min and nifedipine at 6.8 min. The method was validated as per ICH guidelines and linear calibration curve was obtained for the peak area ratio of acalabrutinib and nifedipine compound across a range of 50-3000 ng/mL. Greater than 90% recoveries were obtained for acalabrutinib. The relative standard deviation (%RSD) was found to be < 5% for precision studies. Hence, the method was found to be suitable for the analysis of acalabrutinib in spiked human plasma and is used for the pharmacokinetic study.
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- U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM), Guidance for Industry, Bioanalytical Method Validation (2001).
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References
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM), Guidance for Industry, Bioanalytical Method Validation (2001).
J. Burhenne, J. Anal. Bioanal. Tech., 3, 7 (2012); https://doi.org/10.4172/2155-9872.1000e111
H. Ludwig, Validation of Analytical Methods. Agilent Tech, 2010, 1-65.
G. Tiwari and R. Tiwari, Pharm. Methods, 1, 25 (2010); https://doi.org/10.4103/2229-4708.72226
S. Kollipara, G. Bende, N. Agarwal, B. Varshney and J. Paliwal, Chromatographia, 73, 201 (2011); https://doi.org/10.1007/s10337-010-1869-2
A. Byrd, B. Harrington, S. O’Brien, J.A. Jones, A. Schuh, S. Devereux, J. Chaves, W.G. Wierda, F.T. Awan, J.R. Brown, P. Hillmen, D.M. Stephens, P. Ghia, J.C. Barrientos, J.M. Pagel, J. Woyach, D. Johnson, J. Huang, X. Wang, A. Kaptein, B.J. Lannutti, T. Covey, M. Fardis, J. McGreivy, A. Hamdy, W. Rothbaum, R. Izumi, T.G. Diacovo, A.J. Johnson and R.R. Furman, N. Engl. J. Med., 374, 323 (2016); https://doi.org/10.1056/NEJMoa1509981
J. Wu, M. Zhang and D. Liu, J. Hematol. Oncol., 9, 21 (2016); https://doi.org/10.1186/s13045-016-0250-9
C.Y. Cheah, J.F. Seymour and M.L. Wang, J. Clin. Oncol., 34, 1256 (2016); https://doi.org/10.1200/JCO.2015.63.5904
P. Priyanka, Eur. J. Biomed. Pharm. Sci., 6, 465 (2019).
S. Surendran, D. Paul, S. Pokharkar, S. Choulwar, A. Deshpande, S. Giri and N. Satheeshkumar, J. Pharm. Biomed. Anal., 164, 509 (2019); https://doi.org/10.1016/j.jpba.2018.11.012
A.S. Abdelhameed, A.M. Alanazi, A.H. Bakheit, E.S. Hassan, R.N. Herqash and F.M. Almutairi, Int. J. Biol. Macromol., 127, 536 (2019); https://doi.org/10.1016/j.ijbiomac.2019.01.083
T. Covey, M. Gulranjani, J. Cheung, E. Bibikova, T. Clevenger, F. Krantz, K. Pan, K. Yamaguchi, A. De Jong, B. Van Lith, D. Mittag, R. Izumi, J.C. Byrd, W.G. Wierda, S.M. O'Brien, R.R. Furman and A. Kaptein, Blood, 130(Suppl.1), 1741 (2017); https://doi.org/10.1182/blood.V130.Suppl_1.1741.1741
V.K. Patel, B. Lamothe, M.L. Ayres, J. Gay, K. Balakrishnan, C. Ivan, J. Morse, J.P. Cheung, M. Nelson, M.J. Keating, W.G. Wierda, J.R. Marszalek and V. Gandhi, Leukemia, 32, 920 (2018); https://doi.org/10.1038/leu.2017.321
US Department of Health and Human Services Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Biologics Evaluation and Research (CBER), Guidance for Industry: ICHE6 Good Clinical Practice (1996).