| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1213237 | Journal of Chromatography B | 2012 | 4 Pages |
A bioanalytical assay for the mutated BRAF inhibitor vemurafenib was developed and validated. For the quantitative assay, human plasma samples were pre-treated using protein precipitation with water-acetonitrile (1/3, v/v) containing sorafenib as internal standard. The extract was directly injected into the chromatographic system. This system consisted of a sub-2 μm particle, trifunctional bonded octadecyl silica column with isocratic elution using 0.01% (v/v) of formic acid in a mixture of water and methanol. The eluate was transferred into the electrospray interface with positive ionization and the analyte was detected in the selected reaction monitoring mode of a triple quadrupole mass spectrometer. The assay was validated in a 0.1–100 μg/ml calibration range. Within day precisions were 1.6–3.2%, between day precisions 2.7% and 8.2% and accuracies were between 99% and 106% for the whole calibration range. The drug was stable under all relevant conditions. Finally, the assay was successfully used to assess drug levels in a pharmacokinetic mouse study.
► The first bioanalytical assay for vemurafenib has been reported. ► The assay is simple and fast, precise and accurate. ► Vemurafenib is stable under all conditions relevant for the assay. ► The assay was successfully validated in the 0.1–100 μg/ml calibration range.
