An LC-MS/MS quantification method development and validation for the dabrafenib in biological matrices
Gella Sai Uday Kiran, Sandhya Pasikanti, Shankar Cheruku, DVRN Bhikshapathi, Mamatha Palanati · Journal of Applied Pharmaceutical Science · 2022
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) C 18 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 <4.65%.The high sensitiveness, better accuracy, and precision with good recovery findings for the plasma samples of a developed method prove its applicability for pharmacokinetics and bioequivalence studies.