Review of the article Simple and Rapid LC-MS/MS Method for Determination of Perampanel in Human Plasma and Application to Bioequivalence Study, verified by Publons, Web of Science
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Abstract
Background: Perampanel (PER) is a third-generation anti-epileptic drugs (AEDs). Several methods have been developed for the quantification of perampanel in plasma. The pharmacokinetic characteristics of perampanel in healthy Chinese Subjects have not been comprehensively reported. Objective: A simple, fast and sensitive LCMS/ MS method was established and validated for the quantification of perampanel in human plasma and its application to a bioequivalence study. Methods Chromatographic separation was accomplished on a ZORBAX Eclipse XDB-Phenyl column (4.6 mm × 75 mm, 3.5 μm) using a binary gradient with mobile phase A (5 mmol/L ammonium acetate containing 0.1% formic acid) and B (acetonitrile-water (95:5, v/v)) at a flow rate of 0.9 mL/min and sample preparation was by one-step protein precipitation via acetonitrile. Results: The total run time in this study was 4.5 min and the retention time of perampanel and perampanel-d5 (internal standard) were 2.30 min and 2.32 min, res...pectively. The method was developed and validated over the concentration range of 2.00-500 ng/mL for perampanel, with correlation coefficient greater than 0.9992. The inter-day precision was 3.1%-3.8% and accuracy 98.9%-103.5%. The intra-day precision was 2.4%-6.8% and accuracy 97.6%-104.9%. The extraction recovery ranged from 99.23%-103.84% and the matrix effect was not significant. Perampanel was proved to be stable in solution and human plasma under the different tested conditions. The validated method was successfully applied to a randomized, open-label, 2-period, crossover bioequivalence study in healthy Chinese
subjects, and the results indicated that bioequivalence was achieved for 2 formulations of the 4-mg perampanel tablet under both fasting and fed conditions, and both treatments were safe and well tolerated by all study subjects. Conclusion: The validated method was successfully applied to a bioequivalence study of perampanel in human plasma and has achieved satisfactory results
Izvor:
Current Pharmaceutical Analysis, 2022, 1/BMS-CPA-2021-244-25Kolekcije
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Mašinski fakultetTY - JOUR AU - Jovanović, Tamara PY - 2022 UR - https://machinery.mas.bg.ac.rs/handle/123456789/5785 AB - Abstract Background: Perampanel (PER) is a third-generation anti-epileptic drugs (AEDs). Several methods have been developed for the quantification of perampanel in plasma. The pharmacokinetic characteristics of perampanel in healthy Chinese Subjects have not been comprehensively reported. Objective: A simple, fast and sensitive LCMS/ MS method was established and validated for the quantification of perampanel in human plasma and its application to a bioequivalence study. Methods Chromatographic separation was accomplished on a ZORBAX Eclipse XDB-Phenyl column (4.6 mm × 75 mm, 3.5 μm) using a binary gradient with mobile phase A (5 mmol/L ammonium acetate containing 0.1% formic acid) and B (acetonitrile-water (95:5, v/v)) at a flow rate of 0.9 mL/min and sample preparation was by one-step protein precipitation via acetonitrile. Results: The total run time in this study was 4.5 min and the retention time of perampanel and perampanel-d5 (internal standard) were 2.30 min and 2.32 min, respectively. The method was developed and validated over the concentration range of 2.00-500 ng/mL for perampanel, with correlation coefficient greater than 0.9992. The inter-day precision was 3.1%-3.8% and accuracy 98.9%-103.5%. The intra-day precision was 2.4%-6.8% and accuracy 97.6%-104.9%. The extraction recovery ranged from 99.23%-103.84% and the matrix effect was not significant. Perampanel was proved to be stable in solution and human plasma under the different tested conditions. The validated method was successfully applied to a randomized, open-label, 2-period, crossover bioequivalence study in healthy Chinese subjects, and the results indicated that bioequivalence was achieved for 2 formulations of the 4-mg perampanel tablet under both fasting and fed conditions, and both treatments were safe and well tolerated by all study subjects. Conclusion: The validated method was successfully applied to a bioequivalence study of perampanel in human plasma and has achieved satisfactory results T2 - Current Pharmaceutical Analysis T1 - Review of the article Simple and Rapid LC-MS/MS Method for Determination of Perampanel in Human Plasma and Application to Bioequivalence Study, verified by Publons, Web of Science EP - 25 SP - 1/BMS-CPA-2021-244 UR - https://hdl.handle.net/21.15107/rcub_machinery_5785 ER -
@article{ author = "Jovanović, Tamara", year = "2022", abstract = "Abstract Background: Perampanel (PER) is a third-generation anti-epileptic drugs (AEDs). Several methods have been developed for the quantification of perampanel in plasma. The pharmacokinetic characteristics of perampanel in healthy Chinese Subjects have not been comprehensively reported. Objective: A simple, fast and sensitive LCMS/ MS method was established and validated for the quantification of perampanel in human plasma and its application to a bioequivalence study. Methods Chromatographic separation was accomplished on a ZORBAX Eclipse XDB-Phenyl column (4.6 mm × 75 mm, 3.5 μm) using a binary gradient with mobile phase A (5 mmol/L ammonium acetate containing 0.1% formic acid) and B (acetonitrile-water (95:5, v/v)) at a flow rate of 0.9 mL/min and sample preparation was by one-step protein precipitation via acetonitrile. Results: The total run time in this study was 4.5 min and the retention time of perampanel and perampanel-d5 (internal standard) were 2.30 min and 2.32 min, respectively. The method was developed and validated over the concentration range of 2.00-500 ng/mL for perampanel, with correlation coefficient greater than 0.9992. The inter-day precision was 3.1%-3.8% and accuracy 98.9%-103.5%. The intra-day precision was 2.4%-6.8% and accuracy 97.6%-104.9%. The extraction recovery ranged from 99.23%-103.84% and the matrix effect was not significant. Perampanel was proved to be stable in solution and human plasma under the different tested conditions. The validated method was successfully applied to a randomized, open-label, 2-period, crossover bioequivalence study in healthy Chinese subjects, and the results indicated that bioequivalence was achieved for 2 formulations of the 4-mg perampanel tablet under both fasting and fed conditions, and both treatments were safe and well tolerated by all study subjects. Conclusion: The validated method was successfully applied to a bioequivalence study of perampanel in human plasma and has achieved satisfactory results", journal = "Current Pharmaceutical Analysis", title = "Review of the article Simple and Rapid LC-MS/MS Method for Determination of Perampanel in Human Plasma and Application to Bioequivalence Study, verified by Publons, Web of Science", pages = "25-1/BMS-CPA-2021-244", url = "https://hdl.handle.net/21.15107/rcub_machinery_5785" }
Jovanović, T.. (2022). Review of the article Simple and Rapid LC-MS/MS Method for Determination of Perampanel in Human Plasma and Application to Bioequivalence Study, verified by Publons, Web of Science. in Current Pharmaceutical Analysis, 1/BMS-CPA-2021-244-25. https://hdl.handle.net/21.15107/rcub_machinery_5785
Jovanović T. Review of the article Simple and Rapid LC-MS/MS Method for Determination of Perampanel in Human Plasma and Application to Bioequivalence Study, verified by Publons, Web of Science. in Current Pharmaceutical Analysis. 2022;:1/BMS-CPA-2021-244-25. https://hdl.handle.net/21.15107/rcub_machinery_5785 .
Jovanović, Tamara, "Review of the article Simple and Rapid LC-MS/MS Method for Determination of Perampanel in Human Plasma and Application to Bioequivalence Study, verified by Publons, Web of Science" in Current Pharmaceutical Analysis (2022):1/BMS-CPA-2021-244-25, https://hdl.handle.net/21.15107/rcub_machinery_5785 .