ESTIMATION OF GILTERITINIB IN HUMAN PLASMA BY LC-ESI-MS/MS: METHOD DEVELOPMENT AND VALIDATION

A simple, rapid and sensitive bioanalytical method developed to validate the quantity of Gilteritinib drug in human plasma. The development of method was done with the help of LC-ESI-MS/MS system. This method employs binary normal phase phase liquid chromatography-tandem mass spectroscopy operating in Multiple Reaction Monitoring (MRM) mode for detection. This method uses Electron spray ionization source and operates in positive mode. Solid phase extraction method was used to prepare samples, yielding high recovery rates for both Gilteritinib and its internal standard (ISTD). Chromatographic separation was achieved on column Kinetex, 2.6 µm Biphenyl (50mm × 4.6mm) with a mobile phase comprising Pump-A: 0.1% Formic acid in 10Mm Ammonium format and Pump B: Organic mixture (Methanol: Acetonitrile, 50:50 v/v) at yellow monochromatic light under Ambient temperatuare (25 ±5°C). The analyte and ISTD were eluted at approximately 2.7 minutes with total runtime of 5 minutes. Sample prepration was done by Solid phase extraction and this method yelds recover 75.91% for drug and 77.72% for ISTD respectively. The method demonstrated excellent linearity over a dynamic range of 0.200 ng/mL to 130.000 ng/mL, with correlation coefficients consistently within the acceptable range. The regression analysis were found in range of 0.9989. The accuracy of the method met regulatory criteria, within acceptance limit of ±20 at lower limit of quantification(LLOQ) and ±15% at other concentrations. The method was validated following ICH M10, ANVISA and USFDA guidelines, and confirming its reliability for bioanalytical application in pharmacokinetic and clinical studies.