Review of the article “Development of Two Innovative 96-Microwell-Based Spectrophotometric Assays with High Throughput for Determination of Fluoroquinolone Antibiotics in their Pharmaceutical Formulations“, verified by Publons, Web of Science
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ABSTRACT
Background: Brivaracetam is a novel antiepileptic drug, approved clinically for the treatment of partial onset seizures in adults and adolescents. It has some abuse potential and assigned to Schedule V category under the Controlled Substance Act by the Drug Enforcement Administration. It is essential to develop a faster, simple and highly sensitive method for the quantification of Brivaracetam in human plasma by employing simple liquid-liquid extraction.
Objective: To develop and validate a novel UHPLC-MS/MS method for the estimation of brivaracetam in human plasma samples and application to pharmacokinetic study.
Methods: An ultra high-pressure liquid chromatography-tandem mass spectrometry method was developed and validated according to current regulatory guidelines for bioanalytical methods. Sample processing (50 µL) involved only a simple liquid-liquid extraction by ethyl acetate as extraction solvent. Brivaracetam-d7 was used as internal standard. The chromatographic a...nalysis was performed by a Unisol C18 (4.6 X 100 mm, 5µm) column using 0.1% formic acid in water/acetonitrile (20/80 V/V) as an isocratic mobile phase, at a flow rate of 1.0 mL/min with a run time of 2.2 min. Brivaracetam and its internal standard Brivaracetam D7 were detected and quantified in positive ion mode using multiple reaction monitoring transitions at m/z 213.100→168.100 and m/z 220.000→175.100 respectively. The developed method was applied to assess pharmacokinetic parameters like Cmax, Tmax, t1/2 and AUC for Brivaracetam in healthy, male, adult humans.
Results: The method was validated over a concentration range of 20.000 ng/mL to 4000. 000 ng/mL. Both intra- and inter-assay imprecision and inaccuracy were <15% for all quality control samples. No matrix effect was observed. Pharmacokinetic results showed that test formulation is bioequivalent with reference formulation.
Conclusion: The present assay is faster, highly sensitive and simpler than previously published analytical reports for brivaracetam in human plasma samples and is suitable for pharmacokinetic evaluation of any marketed formulation.
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Current Pharmaceutical Analysis, 2021, 1/BMS-CPA-2020-321-Collections
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Mašinski fakultetTY - JOUR AU - Jovanović, Tamara PY - 2021 UR - https://machinery.mas.bg.ac.rs/handle/123456789/5818 AB - ABSTRACT Background: Brivaracetam is a novel antiepileptic drug, approved clinically for the treatment of partial onset seizures in adults and adolescents. It has some abuse potential and assigned to Schedule V category under the Controlled Substance Act by the Drug Enforcement Administration. It is essential to develop a faster, simple and highly sensitive method for the quantification of Brivaracetam in human plasma by employing simple liquid-liquid extraction. Objective: To develop and validate a novel UHPLC-MS/MS method for the estimation of brivaracetam in human plasma samples and application to pharmacokinetic study. Methods: An ultra high-pressure liquid chromatography-tandem mass spectrometry method was developed and validated according to current regulatory guidelines for bioanalytical methods. Sample processing (50 µL) involved only a simple liquid-liquid extraction by ethyl acetate as extraction solvent. Brivaracetam-d7 was used as internal standard. The chromatographic analysis was performed by a Unisol C18 (4.6 X 100 mm, 5µm) column using 0.1% formic acid in water/acetonitrile (20/80 V/V) as an isocratic mobile phase, at a flow rate of 1.0 mL/min with a run time of 2.2 min. Brivaracetam and its internal standard Brivaracetam D7 were detected and quantified in positive ion mode using multiple reaction monitoring transitions at m/z 213.100→168.100 and m/z 220.000→175.100 respectively. The developed method was applied to assess pharmacokinetic parameters like Cmax, Tmax, t1/2 and AUC for Brivaracetam in healthy, male, adult humans. Results: The method was validated over a concentration range of 20.000 ng/mL to 4000. 000 ng/mL. Both intra- and inter-assay imprecision and inaccuracy were <15% for all quality control samples. No matrix effect was observed. Pharmacokinetic results showed that test formulation is bioequivalent with reference formulation. Conclusion: The present assay is faster, highly sensitive and simpler than previously published analytical reports for brivaracetam in human plasma samples and is suitable for pharmacokinetic evaluation of any marketed formulation. T2 - Current Pharmaceutical Analysis T1 - Review of the article “Development of Two Innovative 96-Microwell-Based Spectrophotometric Assays with High Throughput for Determination of Fluoroquinolone Antibiotics in their Pharmaceutical Formulations“, verified by Publons, Web of Science SP - 1/BMS-CPA-2020-321 UR - https://hdl.handle.net/21.15107/rcub_machinery_5818 ER -
@article{ author = "Jovanović, Tamara", year = "2021", abstract = "ABSTRACT Background: Brivaracetam is a novel antiepileptic drug, approved clinically for the treatment of partial onset seizures in adults and adolescents. It has some abuse potential and assigned to Schedule V category under the Controlled Substance Act by the Drug Enforcement Administration. It is essential to develop a faster, simple and highly sensitive method for the quantification of Brivaracetam in human plasma by employing simple liquid-liquid extraction. Objective: To develop and validate a novel UHPLC-MS/MS method for the estimation of brivaracetam in human plasma samples and application to pharmacokinetic study. Methods: An ultra high-pressure liquid chromatography-tandem mass spectrometry method was developed and validated according to current regulatory guidelines for bioanalytical methods. Sample processing (50 µL) involved only a simple liquid-liquid extraction by ethyl acetate as extraction solvent. Brivaracetam-d7 was used as internal standard. The chromatographic analysis was performed by a Unisol C18 (4.6 X 100 mm, 5µm) column using 0.1% formic acid in water/acetonitrile (20/80 V/V) as an isocratic mobile phase, at a flow rate of 1.0 mL/min with a run time of 2.2 min. Brivaracetam and its internal standard Brivaracetam D7 were detected and quantified in positive ion mode using multiple reaction monitoring transitions at m/z 213.100→168.100 and m/z 220.000→175.100 respectively. The developed method was applied to assess pharmacokinetic parameters like Cmax, Tmax, t1/2 and AUC for Brivaracetam in healthy, male, adult humans. Results: The method was validated over a concentration range of 20.000 ng/mL to 4000. 000 ng/mL. Both intra- and inter-assay imprecision and inaccuracy were <15% for all quality control samples. No matrix effect was observed. Pharmacokinetic results showed that test formulation is bioequivalent with reference formulation. Conclusion: The present assay is faster, highly sensitive and simpler than previously published analytical reports for brivaracetam in human plasma samples and is suitable for pharmacokinetic evaluation of any marketed formulation.", journal = "Current Pharmaceutical Analysis", title = "Review of the article “Development of Two Innovative 96-Microwell-Based Spectrophotometric Assays with High Throughput for Determination of Fluoroquinolone Antibiotics in their Pharmaceutical Formulations“, verified by Publons, Web of Science", pages = "1/BMS-CPA-2020-321", url = "https://hdl.handle.net/21.15107/rcub_machinery_5818" }
Jovanović, T.. (2021). Review of the article “Development of Two Innovative 96-Microwell-Based Spectrophotometric Assays with High Throughput for Determination of Fluoroquinolone Antibiotics in their Pharmaceutical Formulations“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis, 1/BMS-CPA-2020-321. https://hdl.handle.net/21.15107/rcub_machinery_5818
Jovanović T. Review of the article “Development of Two Innovative 96-Microwell-Based Spectrophotometric Assays with High Throughput for Determination of Fluoroquinolone Antibiotics in their Pharmaceutical Formulations“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis. 2021;:1/BMS-CPA-2020-321. https://hdl.handle.net/21.15107/rcub_machinery_5818 .
Jovanović, Tamara, "Review of the article “Development of Two Innovative 96-Microwell-Based Spectrophotometric Assays with High Throughput for Determination of Fluoroquinolone Antibiotics in their Pharmaceutical Formulations“, verified by Publons, Web of Science" in Current Pharmaceutical Analysis (2021):1/BMS-CPA-2020-321, https://hdl.handle.net/21.15107/rcub_machinery_5818 .