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.pdf
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https://doi.org/10.31032/IJBPAS/2021/10.9.1057