A high performance LC-MS/MS method for the estimation of Erlotinib in human plasma
DOI:
https://doi.org/10.56511/JIPBS.2016.v3.i04.pp157-163Abstract
A High Performance Liquid Chromatography Mass Spectrometric Method for the estimation of Erlotinib in human plasma has been developed and validated using Erlotinib D6 as an internal standard (IS). The extraction of analyte and IS was accomplished by Liquid-Liquid Extraction technique. The method has been validated over a concentration range of 1.00ng/mL to 2502.02 ng/mL. Chromatographic separations was achieved using Waters X Bridge C18, 75mm x 4.6mm, 3.5μ, column eluted at flow rate of 0.8 mL/minute with 1:1 splitted post column with mobile phase Acetonitrile: Ammonium acetate buffer pH 9.2 (70:30 v/v).The overall run time of method was about 3.0 min. with elution times of Erlotinib and its internal standard Erlotinib D6 at around 1.3 min. The multiple reaction monitoring transitions were set at 394.2 > 278.1 (m/z) and 400.4 > 278.1 (m/z) for Erlotinib and Erlotinib D6 respectively. The calibration curves were linear (r2 ≥ 0.99) over the range of 1.0-2502.02 ng/mL with lower limit of quantitation validated at 1.0 ng/mL. Extraction recoveries were > 80 % for both Erlotinib and its stable labeled IS Erlotinib D6. The within run and between run precisions were within 0.62%-7.07%, while accuracy ranged from 94.4 to 103.3%.
Keywords:
High performance liquid chromatography, Mass spectrometry, Tyrosine kinase inhibitor, Anticancer, ErlotinibDownloads
References
Moyer, J.D., Barbacci, E.G., Iwata, K.K., Arnold, L., Boman, B., Cunningham, A., DiOrio, C., Doty, J., Morin, M.J., Moyer, M.P., Neveu, M., Pollack, V.A., Pustilnik, L.R., Reynolds, M.M., Sloan, D., Theleman, A., Miller, P.: Induction of apoptosis and cell cycle arrest by CP-358,774, an inhibitor of epidermal growth factor receptor tyrosine kinase, Cancer Res, 1997; 57: 4838-4848.
Bardin, C., Veal, G., Paci, A., Chatelut, E., Astier, A., Levêque, D., Widmer, N., Beijnen, J.: Therapeutic drug monitoring in cancer – Are we missing a trick?, Eur J. Cancer, 2014;50:2005-2009.
Clark, G.M., Zborowski, D.M., Santabárbara, P., Ding, K., Whitehead, M., Seymour, L., Shepherd, F.A.: Smoking History and Epidermal Growth Factor Receptor Expression as Predictors of Survival Benefit from Erlotinib for Patients with Non – Small-Cell Lung Cancer in the National Cancer Institute of Canada Clinical Trials Group Study BR.21, Clinical Lung Cancer, 2006; 7: 389-394.
Ling, J., Fettner, S., Lum, B.L., Riek, M., Rakhit, A.: Effect of food on the pharmacokinetics of erlotinib, an orally active epidermal growth factor receptor tyrosine-kinase inhibitor, in healthy individuals, AntiCancer Drugs, 2008; 19: 209-216.
Thomas, F., Rochaix, P., White-Koning, M., Hennebelle, I., Sarini, J., Benlyazid, A., Malard, L., Lefebvre, J.L., Chatelut, E., Delord, J.P.: Population pharmacokinetics of erlotinib and its pharmacokinetic /pharmacodynamic relationships in head and neck squamous cell carcinoma, Eur J. Cancer, 2009; 45: 2316-2323.
Li, J., Zhao, M., He, P., Hidalgo, M., Baker, S.D.: Differential metabolism of gefitinib and erlotinib by human cytochrome P450 enzymes, Clin. Cancer Res, 2007; 13: 3731-3737.
Ling, J., Johnson, K.A., Miao, Z., Rakhit, A., Pantze, M.P., Hamilton, M., Lum, B.L., Prakash, C.: Metabolism and excretion of erlotinib, a small molecule inhibitor of epidermal growth factor receptor tyrosine kinase, in healthy male volunteers, Drug Metab. Dispos, 2006; 34: 420-426.
Ohgami, M., Homma, M., Suzuki, Y., Naito, K., Yamada, M., Mitsuhashi, S., Fujisawa, F., Kojima, H., Kaburagi, T., Uchiumi, K., Yamada, Y., Bando, H., Hara, H., Takei, K.: A Simple High-Performance Liquid Chromatography for Determining Lapatinib and Erlotinib in Human Plasma. Ther. Drug Monit, 2016; 38(6):657-662.
Zhang, W., Siu, L.L., Moore, M.J., Chen, E.X.: Simultaneous determination of OSI-774 and its major metabolite OSI-420 in human plasma by using HPLC with UV detection, J. Chromatography B, 2005; 814: 143-147. Table 5. Table Dilution Integrity Mean Back Calculated Precision Mean Accuracy - 1 Concentration n=6 (ng m ) (RSD, %) (%) 3867.18 1.33 95.16 3982.79 1.94 98.00
Faivre, L., Gomo, C., Mir, O., Taieb, F., Schoemann-Thomas, A., Ropert, S., Vidal, M., Dusser, D., Dauphin, A., Goldwasser, F., Blanchet, B.: A simple HPLC-UV method for the simultaneous quantification of gefitinib and erlotinib in human plasma, J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 2011; 879: 2345-2350.
Herbrink, M., de Vries, N., Rosing, H., Huitema, A.D., Nuijen, B., Schellens, J.H., Beijnen, J.H.: Quantification of 11 Therapeutic Kinase Inhibitors in Human Plasma for Therapeutic Drug Monitoring Using Liquid Chromatography Coupled With Tandem Mass Spectrometry, Ther. Drug Monit., 2016;38(6):649-656.
Svedberg, A., Gréen, H., Vikström, A., Lundeberg, J., Vikingsson, S.: A validated liquid chromatography tandem mass spectrometry method for quantification of erlotinib, OSI-420 and didesmethylerlotinib and semiquantification of erlotinib metabolites in human plasma, J Pharm Biomed Anal., 2015; 107:186-95.
Chahbouni, A., Ben Burger, J.C., Vos, R.M., Sin jewel, A., Wilhelm, A.J., Simultaneous quantification of Erlotinib Gefitinib and Imatinib in human plasma by liquid chromatography tandem mass spectrometry, Ther. Drug Monit., 2009; 6: 683 – 687.
Maher, H.M., Alzoman, N.Z., Shehata, S.M.: Simultaneous determination of selected tyrosine kinase inhibitors with corticosteroids and antiemetics in rat plasma by solid phase extraction and ultra-performance liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic interaction studies, J. Pharm. Biomed. Anal., 2016; 124:216-27.
Bouchet, S., Chauzit, E., Ducint, D., Castaing, N., Canal-Raffin, M., Moore, N., Titier, K., Molimard, M.: Simultaneous determination of nine tyrosine kinase inhibitors by 96-well solid-phase extraction and ultra performance LC/MS-MS, Clin. Chim. Acta, 2011; 412: 1060-1067.
Honeywell, R., Yarzadah, K., Giovannetti, E., Losekoot, N., Smit, E.F., Walraven, M., Lind, J.S.W., Tibaldi, C., Verheul, H.M., Peters, G.J.: Simple and selective method for the determination of various tyrosine kinase inhibitors used in the clinical setting by liquid chromatography tandem mass spectrometry, J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 2010; 878: 1059-1068.
Götze, L., Hegele, A., Metzelder, S.K., Renz, H., Nockher, W.A.: Development and clinical application of a LC-MS/MS method for simultaneous determination of various tyrosine kinase inhibitors in human plasma, Clin. Chim. Acta, 2012; 413: 143-149.
U.S. Food and Drug Administration. Bioanalytical Method Validation, Guidance for Industry. U.S. department of Health and Human Services Food and Drug Administration, Rockville, MD. 2001.
Obaid Shaikh, Sarfaraz Khan, Zahid Zaheer, Younus Shaikh, Madhukar Tajne: A validated HPTLC method for estimation of Nitazoxanide in bulk and formulation. Journal of Innovations in Applied Pharmaceutical Science 2016; 1(2): 1-7.
Zahid Zaheer, Sarfaraz Khan, Mohammad Sadeque, Mirza Shahed Baig, J. N. Sangshetti: Development and validation of UV spectrophotometric estimation of lisinopril dihydrate in bulk and tablet dosage form using area under curve method. Journal of Innovations in Applied Pharmaceutical Science 2016; 1(2): 12-16.
Zahid Zaheer, Sarfaraz Khan, Mohammad Sadeque, G. I. Hundekari, Rana Zainuddin: Development and validation for determination of lisinopril dihydrate in bulk drug and formulation using RP-HPLC method, Journal of Innovations in Applied Pharmaceutical Science 2016; 1(2): 1721.
Zahid Zaheer, Furquan Nazimuddin Khan, Darakhshan Afreen Shaikh, Sarfaraz Khan, Mirza Shahed Baig, Moizul Hasan, Zero order derivative spectroscopic estimation of olopatadine hydrochloride from eye drops. Journal of Innovations in Pharmaceutical and Biological Sciences 2016; 3(2): 103-107.
Sarfaraz Khan, Mohammad Sadeque, J. N. Sangshetti, Zahid Zaheer: Development of analytical method and validation for determination of Lisinopril dihydrate in bulk drug and dosage form using HPTLC method, Journal of Inventions in Biomedical and Pharmaceutical Sciences 2016; 1(1): 5-9.
Published
How to Cite
Issue
Section
Copyright (c) 2016 Mirza Layeeq Ahmed Baig, Syed Ayaz Ali
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Journal of Innovations in Pharmaceutical and Biological Sciences is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Based on a work at