A NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DASATINIB IN HUMAN PLASMA BY LC–ESI-MS/MS Authors: G. Sai Uday Kiran, P. Sandhya*
ABSTRACT
A specific and selective liquid chromatography/tandem mass spectrometry (LC–MS/MS)
technique was desirable for the assessment of dasatinib in human plasma. Drug and internal
standard were extracted utilizing liquid–liquid extraction technique using ethyl acetate and
methanol in proportion of 4:2. Reversed phase high performance liquid chromatography (RPHPLC) was carried out using Zorbax (50×4.6 mm i.d., 5 µm) C18 analytical column with a
simple isocratic mobile phase composed of 0.1% formic acid, methanol and acetonitrile,
(10:30:60, v/v). Detection was executed on a triple quadrupole mass spectrometer retaining
electrospray ionization method, operating in multiple reaction monitoring (MRM), with the
transitions of m/z 488.16/140.02 for dasatinib and m/z 496.15/144.2 for dasatinib-D8,
respectively, in the positive ionization mode. The linearity was processed a concentration range
of 1.0–1200.0 ng/mL for the analyte. All obtained recoveries were higher than 91.0% while the
accuracy was in the range of 1.52% to 3.48% of relative error and the relative standard deviation
was below 4.11% for all investigated drugs by the proposed method. The validated method has
highly sensitive and nice recoveries values from plasma, utilized for the bioequivalence and
pharmacokinetic studies.
Keywords: Dasatinib, Cancer, LC–MS/MS, Validation, Sensitivity and Accuracy Publication date: 25/09/2021 https://ijbpas.com/pdf/2021/September/MS_IJBPAS_2021_SEPT_SPCL_1057.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2021/10.9.1057