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Bioanalytical Method Validation of Dasatinib in Human Plasma Using the LC-MS/MS Method

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DOI: 10.21522/TIJCR.2014.07.01.Art002

Authors : Aruna Singam Reddy, Manoj Jadhav, T. Vijaya Kumar, Radhika Inapakolla

Abstract:

A sensitive and selective LC-MS/MS method for estimation of Dasatinib in K2EDTA human plasma was developed and validated. The concentration range was 1.0 ng/mL to 800.0 ng/mL. Sample preparation and analysis are carried out for Dasatinib as analyte using Dasatinib D8 as internal standard. Analyte was separated by reverse phase chromatography using Thermo Hypurity C8 100*4.6 mm Column. Electro spray Ionization detections of Dasatinib, Dasatinib D8 were carried out with multiple reaction monitoring of m/z 488.1/401.1, 496.1/406.1 respectively in positive ion mode [M+H] + using a triple quadruple mass spectrometer. The retention time for Dasatinib and Dasatinib D8 was 1.36 Minutes ± 30 seconds and 1.37 Minutes ± 30 seconds respectively with a total run time of 2.50 minutes. No interfering peaks or matrix effects were observed. This article provides the results of standard curves, quality control samples, recovery, and stability experiments. The LC-MS/MS method for the determination of Dasatinib in human plasma has specifications for sensitivity, reproducibility and accuracy.

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