A Liquid Chromatography‐Tandem Mass Spectrometry Bioanalytical Method Development and Validation for the Determination of Pacritinib in Plasma

ABSTRACT The primary objective of the current work is to establish and verify an accurate and linear liquid chromatography‐electrospray ionization‐tandem mass spectrometry procedure for quantifying Pacritinib. An effective chromatographic resolution was obtained using the Hypersil Gold (50 × 4.6 mm, 2.1 µm) C18 column. The mobile phase is a mixture of methanol, 0.1% formic acid, and acetonitrile in the proportion of 20:15:65 (%v/v/v). The procedure involved closely monitoring executed ionic transitions of m/z 473.1/376.2 for Pacritinib and 584.26/101.1 for Brigatinib internal standard in multiple reaction monitoring mode. A strong correlation value ( r 2 ) of 0.9997 is associated with the linear plot regression line, which can be represented as y = 0.0001 x − 0.0008. The relative standard deviation (RSD) results for the matrix effect were 3.63% and 3.57%, respectively, when the quality control (QC) level was low and high, respectively. Over the course of the study, the percentage average recoveries for Pacritinib were found to be 103.27% in high QC, 97.59% in medium QC, and 94.28% in low QC, respectively. The values that were obtained for the QC samples (0.378, 1.058, 7.56, and 11.34 µg/mL) varied from 2.00% to 4.03%. The developed method was useful for evaluating Pacritinib in biological samples for the purposes of QC, forensics, and bioavailability investigations for individuals.