Development and validation of an ultra-high-performance liquid chromatography-tandem mass spectrometry method to determine the bioavailability of warfarin and its major metabolite 7-hydroxy warfarin in rats dosed with oral formulations containing different polymorphic forms
© 2019 John Wiley & Sons, Ltd..
A simple, sensitive and rapid ultra-high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry method was developed and validated for the quantification of warfarin and 7-hydroxy warfarin in Sprague Dawley (SD) rats. Animals were administered a single dose of warfarin sodium formulations (crystalline and amorphous) at 12 mg/kg via oral gavage and blood was drawn over a 96-h time course. Sample process recoveries, matrix effect and analyte stability were determined. The linearity for warfarin and 7-hydroxy warfarin was from 5 to 2000 ng/mL in blank SD rat plasma. Correlation coefficients (r2 ) for standard calibration curves were >.98 and analytes quantified within ±15% of target at all calibrator concentrations. The average percent accuracy and precision for intra- and inter-day were 93.7%-113.8% and ≤12.1%, respectively, for warfarin and 7-hydroxy warfarin, across the quality control standards (5, 10, 500, 1800 and 2000 ng/mL). Acceptable analytical recovery (>55%) was achieved with process efficiencies >41.5% and matrix effects <139.9% over the analytical range. Both analytes were stable in stock solution, autosampler, benchtop and three cycles of freeze-thaw with percent accuracy ≥90.2% and precision (percent relative standard deviation) ≤14%. The validated method was successfully applied to a pre-clinical bioavailability study of crystalline and amorphous warfarin sodium formulations in SD rats.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:33 |
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| Enthalten in: |
Biomedical chromatography : BMC - 33(2019), 12 vom: 21. Dez., Seite e4685 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shakleya, Diaa [VerfasserIn] |
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| Links: |
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| Themen: |
5Q7ZVV76EI |
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| Anmerkungen: |
Date Completed 27.12.2019 Date Revised 08.01.2020 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/bmc.4685 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM300407513 |
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| 245 | 1 | 0 | |a Development and validation of an ultra-high-performance liquid chromatography-tandem mass spectrometry method to determine the bioavailability of warfarin and its major metabolite 7-hydroxy warfarin in rats dosed with oral formulations containing different polymorphic forms |
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| 520 | |a © 2019 John Wiley & Sons, Ltd. | ||
| 520 | |a A simple, sensitive and rapid ultra-high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry method was developed and validated for the quantification of warfarin and 7-hydroxy warfarin in Sprague Dawley (SD) rats. Animals were administered a single dose of warfarin sodium formulations (crystalline and amorphous) at 12 mg/kg via oral gavage and blood was drawn over a 96-h time course. Sample process recoveries, matrix effect and analyte stability were determined. The linearity for warfarin and 7-hydroxy warfarin was from 5 to 2000 ng/mL in blank SD rat plasma. Correlation coefficients (r2 ) for standard calibration curves were >.98 and analytes quantified within ±15% of target at all calibrator concentrations. The average percent accuracy and precision for intra- and inter-day were 93.7%-113.8% and ≤12.1%, respectively, for warfarin and 7-hydroxy warfarin, across the quality control standards (5, 10, 500, 1800 and 2000 ng/mL). Acceptable analytical recovery (>55%) was achieved with process efficiencies >41.5% and matrix effects <139.9% over the analytical range. Both analytes were stable in stock solution, autosampler, benchtop and three cycles of freeze-thaw with percent accuracy ≥90.2% and precision (percent relative standard deviation) ≤14%. The validated method was successfully applied to a pre-clinical bioavailability study of crystalline and amorphous warfarin sodium formulations in SD rats | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a 7-hydroxy warfarin, amorphous, bioavailability, crystalline, LC-ESI-MS/MS, warfarin | |
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| 700 | 1 | |a Faustino, Patrick J |e verfasserin |4 aut | |
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