An LC–MS/MS quantification method development and validation for the dabrafenib in biological matrices

Abstract

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.

Stability Indicating an LC-MS/MS Method Development and Validation for the Quantification of Capmatinib in Human Plasma

“…Specificity, accuracy, linearity, precision, stability, and recovery were among the validation criteria. [12][13][14][15][16][17][18][19]…”

“…Figure 2B shows blank plasma that has been spiked with the IS at a concentration of 750 ng/mL. [15][16][17][18]…”

“…Comparison of the peak heights of spiked-before-extraction samples and spiked-after-extraction samples (6 sets) was used to calculate the extraction recovery of capmatinib at three different concentrations (0.6, 1600, and 2400 ng/mL) and the IS at one concentration (750 ng/mL). 18 This was done in order to determine the IS at one concentration. The average measured recovery of capmatinib after extraction was 99.23% (Figure 4 and Table 3).…”