Determination of ebrotidine and its metabolites in human urine by reversed-phase ion-pair high-performance liquid chromatography |
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| Institution: | 1. Cardiothoracic Department, via Paradisa 2, 56124 Pisa, Italy;2. DV University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania;3. Cardiovascular Research Centre, University of Alberta, Edmonton, Alberta, Canada;4. Chinese PLA General Hospital, China;5. Kokilaben Dhirubhai Ambani Hospital, Mumbai, India;6. Department of Cardiology, HEGP, AP-HP, 75015 Paris, France;7. Université Paris-Descartes, 75006 Paris, France;8. Department of Cardiology, Ain Shams University Hospitals, Cairo, Egypt;9. Centro Cardiologico Universitario di Ferrara, University of Ferrara, Italy;10. Heart Institute, Sao Paulo, Brazil;11. Volgograd State Medical University, Cardiology Center, Volgograd, Russia;12. Department for Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb, Croatia;13. Institute of Cardiology, Kiev, Ukraine;14. Faculty of Medicine, University of Lisbon, Portugal;15. Cardiology Department, Heart and Vascular Department, University Hospital, CHLN, Portugal;p. Centre for Heart Diseases, Military Hospital, 50-981 Wroc?aw, Poland;q. University of Belgrade School of Medicine, Serbia;r. Cardiovascular and Cell Sciences Research Institute, St George''s University, London, UK;s. IRCCS San Raffaele Pisana, Rome, Italy;1. Department B of Gynecologic Surgery, Tunis Maternity Center, Tunis Medical School, El Manar University, Tunisia;2. Maternity Department of Tunis Military Hospital, Tunis Medical School, El Manar University, Tunisia |
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| Abstract: | Ebrotidine is a new H2-receptor antagonist with powerful antisecretory activity, demonstrated gastroprotection and the ability to inhibit protease and lipase activities of Helicobacter pylori. As a tool in the clinical pharmacokinetic study of ebrotidine, an analytical method for the simultaneous determination of ebrotidine an its metabolites in human urine was developed. An ion-pair reversed-phase HPLC separation using 1-hexanesulfonic acid and acetonitrile as mobile phase with gradient elution was optimized. In addition, several procedures of preconcentration and clean-up were tested, including solid-phase and liquid—liquid extraction, the mixture dichloromethane—2-propanol (9:1, v/v) at pH 11 being the most efficient. The quality parameters of the whole analytical method were established, the calibration curves were linear over the range studied (1–200 μg/ml) and the reproducibility of the method was high (inter-day R.S.D. values lower than 4.4%).The limits of detection were between 26 and 110 ng/ml of urine for ebrotidine and its metabolites. The method was applied to the analysis of urine collected from two volunteers during 96 h following oral administration of ebrotidine at a dose of 400 mg. |
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