A New Rapid and Sensitive LC-MS Assay for the Determination of Sorafenib in Plasma: Application to a Patient Undergoing Hemodialysis
| Autor: | Christine Bobin-Dubigeon, Chantal Le Guellec, Alexandra Heurgue-Berlot, Marie-Bernadette Amiand, Olivier Bouché, Jean-Marie Bard |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Niacinamide Sorafenib Spectrometry Mass Electrospray Ionization Analyte Carcinoma Hepatocellular Pyridines Formic acid medicine.medical_treatment Antineoplastic Agents Mass spectrometry chemistry.chemical_compound Fatal Outcome Drug Stability Limit of Detection Renal Dialysis Liquid chromatography–mass spectrometry medicine Humans Pharmacology (medical) Protein Kinase Inhibitors Chromatography High Pressure Liquid Pharmacology Detection limit Chromatography Phenylurea Compounds Benzenesulfonates Liver Neoplasms Solid Phase Extraction Extraction (chemistry) Reproducibility of Results Middle Aged chemistry Calibration Kidney Failure Chronic Hemodialysis medicine.drug |
| Zdroj: | Therapeutic Drug Monitoring. 33:705-710 |
| ISSN: | 0163-4356 |
| DOI: | 10.1097/ftd.0b013e3182357891 |
| Popis: | A simple liquid chromatography-mass spectrometry method was developed and validated for quantification of sorafenib (Nexavar) in human plasma. After a solid-phase extraction procedure, the separation was performed within 2 minutes using an isocratic flow of a mobile phase consisting of formic acid/acetonitrile applied on a C18 analytical column. The analyte was detected by mass spectrometry in the single-ion monitoring mode. The method was validated according to the recommendations of the US Food and Drug Administration. The method was linear (r² > 0.99) between 10 and 10,000 ng/mL. The lower limits of detection and quantification were 5 and 10 ng/mL, respectively. Within-day and between-day imprecisions were less than 10.4%, and inaccuracy did not exceed 8.7%. The mean extraction recovery was 92.2%. The method also provided satisfactory results in terms of time stability and dilution integrity. Sorafenib plasma concentrations of the studied patient ranged between 1831 and 3459 ng/mL. This new technique is rapid, sensitive, and was applied to the determination of sorafenib plasma concentrations in a patient undergoing hemodialysis. Our results indicate that sorafenib is not cleared from plasma by hemodialysis, although analysis should be delayed after dialysis to avoid erratic fluctuations. |
| Databáze: | OpenAIRE |
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