An accurate, specific, and robust liquid chromatography–tandem mass spectrometry technique was developed and validated for the quantification of dabrafenib in plasma samples. Internal standard and drug components were subjected to extraction by utilizing liquid–liquid extraction method by utilizing ethyl acetate. high performance liquid chromatography of reverse phase was operated with Phenomenex (50×4.60 mm, 5.0 μm) C18 analytical column, isocratic system of mobile solvent comprised acetonitrile and formic acid (0.1%) (85:15, %V/V). Mass triple quadrupole detection system was utilized for the analysis. Electrospray ionization in the positive ionization approach method operated in multiple reactions monitoring with ionic transition of m/z 520.10–176.98, m/z 465.09–244.10 for dabrafenib, sorafenib, respectively. Rectilinear plot was processed in concentration levels of 74–2,956 ng.ml−1 and the method validation was executed as per the United States Food and Drug Administration strategies for bio analytical methods. The recovery findings obtained were more than 92.5% and the accurateness was fall in between–1.53% and 2.94% of relative error and % relative standard deviation findings were
Key words: Dabrafenib, Kinase inhibitor, LC–MS/MS, Validation, Precision and Matrix effect.
|
