Spiked Human Plasma Samples: Stability Indicating Method Development and Validation of Pexidartinib by LCMS

Aim:

Pexidartinib (PDTB) was utilized in the development of a novel bioanalytical LCMS method in human plasma, with Talazoparib (TZPB) serving as the IS (Internal standard).

Materials and Methods:

The chromatographic separation was accomplished using an Xbridge C18 column (50 mM×4.6 mM, 5 μM) with an Acetonitrile-based simple isocratic mobile phase composition: Throughout the study, 0.6 mL/min of methanaol:0.1% orthophosphoric acid (35:35:30) was flow-regulated.

Results and Discussion:

In the positive ion mode, mass spectra of Pexidartinib (PDTB) and Talazoparib (TZPB) were discovered at m/z 418→153 and m/z 381→108, respectively. The study took 5 min to complete and had a strong linearity in the 0.5-500 ng/mL range with a correlation coefficient (r) of 0.999. The original ranges for the % RSD of the method and the intermediate precision of the PDTB were 0.29-1.13 and 0.13-1.01, respectively. LOD and LOQ were 0.5 μg mL^-1 and 0.05 μg mL^-1, respectively, and more than 90.0% of the samples were recovered.

Conclusion:

The bioanalytical method's validation was conducted in compliance with the ICH recommendations. The proposed LC-MS method has been effectively applied for routine analysis and bioanalysis, thanks to the produced promising results that are simple, precise, reliable, sensitive, and robust.