Review of the article „Quantification of Rebamipide in Human Plasma by HPLC-MS/MS and Application to a Pharmacokinetic Study in Chinese Healthy Volunteers“, verified by Publons, Web of Science
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Abstract:
Background: Rebamipide was widely used for the treatment of gastric ulcer, gastritis, gastric mucosal lesions, but the large inter-individual variability in PK parameters was observed. The aim of this study was to investigate the pharmacokinetic of rebamipide in healthy Chinese volunteers, which is critical to the safety and efficacy.
Method: A selective and sensitive liquid chromatography–tandem mass spectrometry method was developed for the determination of rabamipide in human plasma. The separation was performed on Inertsil®ODS-3 column (150×4.6mm, 5m), with a mobile phase constituted by methanol and 1% formic acid (70:30, V/V), with the flow-rate at 0.6ml/min. The detection was carried out on Agilent 6410 Triple Quadrupole mass spectrometer under positive-ion multiple reaction monitoring mode, and the respective mass transitions used for quantification of rebamipide and carbamazepine (internal standard, IS) were m/z 371.3→216.4 and m/z 237.2→194.2. The validated metho...d was applied in the pharmacokinetic study of rebamipide in Chinese healthy volunteers under fasted condition.
Results: Calibration curves were linear over the concentration range of 5-400ng/ml. After single oral dose of 100 mg, the main pharmacokinetic parameters of rebamipide were as follows: Cmax (165.11±50.53 ng/mL), AUC0-t (637.30±208.67 ng∙h/mL ), Tmax (2.71±1.18 h), t1/2 (1.63±0.51 h). Double peak phenomenon was observed in mean plasma concentration curves.
Conclusion: The HPLC-MS/MS method developed in this article was proved to be of great accuracy and precision, suitable for the rapid batch determination of rabamipide in pharmacokinetic and clinical studies. The pharmacokinetic of rabamipide in healthy Chinese volunteers was investigated according to this method, A secondary peak was observed in mean plasma concentration curves.
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Current Pharmaceutical Analysis, 2019, 1/BMS-CPA-2018-261-17Колекције
Институција/група
Mašinski fakultetTY - JOUR AU - Jovanović, Tamara PY - 2019 UR - https://machinery.mas.bg.ac.rs/handle/123456789/6111 AB - Abstract: Background: Rebamipide was widely used for the treatment of gastric ulcer, gastritis, gastric mucosal lesions, but the large inter-individual variability in PK parameters was observed. The aim of this study was to investigate the pharmacokinetic of rebamipide in healthy Chinese volunteers, which is critical to the safety and efficacy. Method: A selective and sensitive liquid chromatography–tandem mass spectrometry method was developed for the determination of rabamipide in human plasma. The separation was performed on Inertsil®ODS-3 column (150×4.6mm, 5m), with a mobile phase constituted by methanol and 1% formic acid (70:30, V/V), with the flow-rate at 0.6ml/min. The detection was carried out on Agilent 6410 Triple Quadrupole mass spectrometer under positive-ion multiple reaction monitoring mode, and the respective mass transitions used for quantification of rebamipide and carbamazepine (internal standard, IS) were m/z 371.3→216.4 and m/z 237.2→194.2. The validated method was applied in the pharmacokinetic study of rebamipide in Chinese healthy volunteers under fasted condition. Results: Calibration curves were linear over the concentration range of 5-400ng/ml. After single oral dose of 100 mg, the main pharmacokinetic parameters of rebamipide were as follows: Cmax (165.11±50.53 ng/mL), AUC0-t (637.30±208.67 ng∙h/mL ), Tmax (2.71±1.18 h), t1/2 (1.63±0.51 h). Double peak phenomenon was observed in mean plasma concentration curves. Conclusion: The HPLC-MS/MS method developed in this article was proved to be of great accuracy and precision, suitable for the rapid batch determination of rabamipide in pharmacokinetic and clinical studies. The pharmacokinetic of rabamipide in healthy Chinese volunteers was investigated according to this method, A secondary peak was observed in mean plasma concentration curves. T2 - Current Pharmaceutical Analysis T1 - Review of the article „Quantification of Rebamipide in Human Plasma by HPLC-MS/MS and Application to a Pharmacokinetic Study in Chinese Healthy Volunteers“, verified by Publons, Web of Science EP - 17 SP - 1/BMS-CPA-2018-261 UR - https://hdl.handle.net/21.15107/rcub_machinery_6111 ER -
@article{ author = "Jovanović, Tamara", year = "2019", abstract = "Abstract: Background: Rebamipide was widely used for the treatment of gastric ulcer, gastritis, gastric mucosal lesions, but the large inter-individual variability in PK parameters was observed. The aim of this study was to investigate the pharmacokinetic of rebamipide in healthy Chinese volunteers, which is critical to the safety and efficacy. Method: A selective and sensitive liquid chromatography–tandem mass spectrometry method was developed for the determination of rabamipide in human plasma. The separation was performed on Inertsil®ODS-3 column (150×4.6mm, 5m), with a mobile phase constituted by methanol and 1% formic acid (70:30, V/V), with the flow-rate at 0.6ml/min. The detection was carried out on Agilent 6410 Triple Quadrupole mass spectrometer under positive-ion multiple reaction monitoring mode, and the respective mass transitions used for quantification of rebamipide and carbamazepine (internal standard, IS) were m/z 371.3→216.4 and m/z 237.2→194.2. The validated method was applied in the pharmacokinetic study of rebamipide in Chinese healthy volunteers under fasted condition. Results: Calibration curves were linear over the concentration range of 5-400ng/ml. After single oral dose of 100 mg, the main pharmacokinetic parameters of rebamipide were as follows: Cmax (165.11±50.53 ng/mL), AUC0-t (637.30±208.67 ng∙h/mL ), Tmax (2.71±1.18 h), t1/2 (1.63±0.51 h). Double peak phenomenon was observed in mean plasma concentration curves. Conclusion: The HPLC-MS/MS method developed in this article was proved to be of great accuracy and precision, suitable for the rapid batch determination of rabamipide in pharmacokinetic and clinical studies. The pharmacokinetic of rabamipide in healthy Chinese volunteers was investigated according to this method, A secondary peak was observed in mean plasma concentration curves.", journal = "Current Pharmaceutical Analysis", title = "Review of the article „Quantification of Rebamipide in Human Plasma by HPLC-MS/MS and Application to a Pharmacokinetic Study in Chinese Healthy Volunteers“, verified by Publons, Web of Science", pages = "17-1/BMS-CPA-2018-261", url = "https://hdl.handle.net/21.15107/rcub_machinery_6111" }
Jovanović, T.. (2019). Review of the article „Quantification of Rebamipide in Human Plasma by HPLC-MS/MS and Application to a Pharmacokinetic Study in Chinese Healthy Volunteers“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis, 1/BMS-CPA-2018-261-17. https://hdl.handle.net/21.15107/rcub_machinery_6111
Jovanović T. Review of the article „Quantification of Rebamipide in Human Plasma by HPLC-MS/MS and Application to a Pharmacokinetic Study in Chinese Healthy Volunteers“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis. 2019;:1/BMS-CPA-2018-261-17. https://hdl.handle.net/21.15107/rcub_machinery_6111 .
Jovanović, Tamara, "Review of the article „Quantification of Rebamipide in Human Plasma by HPLC-MS/MS and Application to a Pharmacokinetic Study in Chinese Healthy Volunteers“, verified by Publons, Web of Science" in Current Pharmaceutical Analysis (2019):1/BMS-CPA-2018-261-17, https://hdl.handle.net/21.15107/rcub_machinery_6111 .