Development and validation of a high-performance liquid chromatographic method with a fluorescence detector for the analysis of epirubicin in human urine and plasma, and its application in drug monitoring

Natalia Treder1, Olga Maliszewska1, Ilona Olędzka1, Piotr Kowalski1, Natalia Miękus1,2, Tomasz Bączek1, Ewa Bień3, Małgorzata Anna Krawczyk3, Elżbieta Adamkiewicz-Drożynska3, Alina Plenis1
1Department of Pharmaceutical Chemistry, Medical University of Gdańsk, Hallera 107, 80-416 Gdańsk, Poland
2Department of Animal and Human Physiology, Faculty of Biology, University of Gdańsk, Wita Stwosza 59, 80-308, Gdańsk, Poland
3Department of Pediatrics, Hematology and Oncology, Medical University Gdańsk, Dębinki 7, 80-211 Gdańsk, Poland

Tài liệu tham khảo

Marinello, 2018, Anthracyclines as Topoisomerase II poisons: from early studies to new perspectives, Int. J. Mol. Sci., 19, 3480, 10.3390/ijms19113480 Cappetta, 2017, Oxidative stress and cellular response to doxorubicin: a common factor in the complex milieu of anthracycline cardiotoxicity, Oxid. Med. Cell. Longev., 13, 2017 Shi, 2011, Mechanisms and management of doxorubicin cardiotoxicity, Herz, 36, 296, 10.1007/s00059-011-3470-3 Yamaguchi, 2015, Comparison of cardiac events associated with liposomal doxorubicin, epirubicin and doxorubicin in breast cancer: a Bayesian network meta-analysis, Eur. J. Cancer, 51, 2314, 10.1016/j.ejca.2015.07.031 H. Li, B. Hu, Z. Guo, X. Jiang, X. Su, X. Zhang, Correlation of UGT2B7 polymorphism with cardiotoxicity in breast cancer patients undergoing epirubicin/cyclophosphamide-docetaxel adjuvant chemotherapy, Yonsei Med. J. 60 (2019) 30–37. 10.3349%2Fymj.2019.60.1.30. Gammella, 2014, The role of iron in anthracycline cardiotoxicity, Front. Pharm. 5, 25 Parmar, 2011, Impact of UGT2B7 His268Tyr polymorphism on the outcome of adjuvant epirubicin treatment in breast cancer, Breast Cancer Res., 13, R57, 10.1186/bcr2894 Mongan, 2015, Outcomes in gastric and junctional cancer using neoadjuvant and adjuvant chemotherapy (epirubicin, oxaliplatin, and capecitabine) and radical surgery, Ir. J. Med. Sci., 184, 417, 10.1007/s11845-014-1135-y Özgül, 2014, Addition of epirubicin to conventional chemotherapy in patients with advanced ovarian cancer: sequential therapy -a retrospective evaluation, Turk. J. Med. Sci., 44, 212, 10.3906/sag-1203-69 Prestwich, 2007, Fatal pneumonitis in children with metastatic rhabdomyosarcoma following whole lung radiotherapy and sequential epirubicin, Pediatr. Blood Cancer., 48, 586, 10.1002/pbc.20660 Huang, 2018, Epirubicin induces apoptosis in osteoblasts through death-receptor and mitochondrial pathways, Apoptosis, 23, 226, 10.1007/s10495-018-1450-2 Fogarassy, 2019, Risk prediction model for long-term heart failure incidence after epirubicin chemotherapy for breast cancer – A real-world data-based, nationwide classification analysis, Int. J. Cardiol., 285, 47, 10.1016/j.ijcard.2019.03.013 Cassinelli, 1984, Separation, Characterization, and analysis of epirubicin (4’ -epidoxorubicin) and its metabolites from human urine, Drug Metab. Dispos., 12, 506 Camaggi, 1988, HPLC analysis of doxorubicin, epirubicin and fluorescent metabolites in biological fluids, Cancer Chemother. Pharmacol., 21, 216, 10.1007/BF00262773 Barker, 1996, Determination of plasma concentrations of epirubicin and its metabolites by high-performance liquid chromatography during a 96-h infusion in cancer chemotherapy, J. Chromatogr. B. Biomed. Appl., 681, 323, 10.1016/0378-4347(96)00030-8 Li, 2007, Hydrophilic interaction chromatographic determination of epirubicin in human plasma using solid phase extraction for sample clean-up, J. Liq. Chromatogr. Relat. Technol., 30, 2409, 10.1080/10826070701465654 Sottani, 2009, Validation of an LC-MS/MS method for the determination of epirubicin in human serum of patients undergoing Drug Eluting Microsphere-Transarterial Chemoembolization (DEM-TACE), J. Chromatogr. B. Anal. Technol. Biomed. Life Sci., 877, 3543, 10.1016/j.jchromb.2009.08.054 Li, 2005, Ultra performance liquid chromatography-tandem mass spectrometry for the determination of epirubicin in human plasma, Anal. Chim. Acta, 546, 167, 10.1016/j.aca.2005.04.073 Dodde, 2003, Determination of epirubicin and its metabolite epirubicinol in saliva and plasma by HPLC, Ther. Drug Monit., 25, 433, 10.1097/00007691-200308000-00003 Ricciarello, 1998, Simultaneous determination of epirubicin, doxorubicin and their principal metabolites in human plasma by high-performance liquid chromatography and electrochemical detection, J. Chromatogr. B., 707, 219, 10.1016/S0378-4347(97)00610-5 Maudens, 2009, Development and validation of a liquid chromatographic method for the simultaneous determination of four anthracyclines and their respective 13-S-dihydro metabolites in plasma and saliva, J. Chromatogr. B. Anal. Tech. Biomed. Life Sci., 877, 3907, 10.1016/j.jchromb.2009.09.044 Fogli, 1999, An improved HPLC method for therapeutic drug monitoring of daunorubicin, idarubicin, doxorubicin, epirubicin, and their 13-dihydro metabolites in human plasma, Ther. Drug Monit., 21, 367, 10.1097/00007691-199906000-00022 Dobbs, 1991, Measurement of epidoxorubicin and its metabolites by high-performance liquid chromatography using an advanced automated sample processor, J. Chromatogr. B. Biomed. Sci. App., 572, 211, 10.1016/0378-4347(91)80485-U Dine, 1990, Rapid quantitative determination of epirubicin and its metabolites in plasma using high performance liquid chromatography and fluorescence detection, Biomed. Chromatogr., 4, 20, 10.1002/bmc.1130040103 Wall, 2007, Rapid and sensitive liquid chromatography-tandem mass spectrometry for the quantitation of epirubicin and identification of metabolites in biological samples, Talanta, 72, 145, 10.1016/j.talanta.2006.10.010 Lachâtre, 2000, Simultaneous determination of four anthracyclines and three metabolites in human serum by liquid chromatography-electrospray mass spectrometry, J. Chromatogr. B. Biomed. Sci. Appl., 738, 281, 10.1016/S0378-4347(99)00529-0 Bermingham, 2010, Simultaneous determination of anthracyclines and taxanes in human serum using online sample extraction coupled to high performance liquid chromatography with UV detection, J. Sep. Sci., 33, 1571, 10.1002/jssc.201000026 Sottani, 2004, Trace determination of anthracyclines in urine: A new high-performance liquid chromatography/tandem mass spectrometry method for assessing exposure of hospital personnel, Rapid. Commun. Mass Spectrom., 18, 2426, 10.1002/rcm.1642 Sottani, 2008, Simultaneous determination of cyclophosphamide, ifosfamide, doxorubicin, epirubicin and daunorubicin in human urine using high-performance liquid chromatography/electrospray ionization tandem mass spectrometry: bioanalytical method validation, Rapid. Commun. Mass Spectrom., 22, 2645, 10.1002/rcm.3657 Fabrizi, 2016, Dispersive solid-phase extraction procedure coupled to UPLC-ESI-MS/MS analysis for the simultaneous determination of thirteen cytotoxic drugs in human urine, Biomed. Chromatogr., 30, 1297, 10.1002/bmc.3684 Nicholls, 1993, Solid-phase extraction and optimized separation of doxorubicin, epirubicin and their metabolites using reversed-phase high-performance liquid chromatography, J. Pharm. Biomed. Anal., 10, 949, 10.1016/0731-7085(91)80104-H Shin, 2013, Validation of high-performance liqid chromatography method to determine epirubicin and its pharmacokinetics after intravenous bolus administration in rats, J. Pharm. Investig., 43, 243, 10.1007/s40005-013-0076-1 US Food Drug Administration, FDA Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human, Services Food and Drug Administration, 2013, https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf (Accessed at: 23.08.19). European Medicines Agency, Guide to Bioanalytical Method Validation, Committee for Medicinal Products for Human Use and European Medicines Agency, 2011, https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf, (Accessed at: 23.08.19.).