Development and validation of stability indicating liquid chromatography tandem mass spectrometry method for the determination of Dasatinib in bulk

Abstract

Dasatinib is a medication used primarily to treat chronic myelogenous leukemia and selected cases of acute lymphoblastic leukemia. In the present study a validated stability-indicating LC-MS/MS method was developed for the estimation of Dasatinib and its degradants on Hypersil ODS (150mm x 4.6 mm i.d., 5µ) column using Methanol: 10mM Ammonium Formate as the mobile phase in a isocratic elution at a flow rate of 1.0 mL/min. The method was validated for accuracy, precision and linearity as per the ICH guidelines. The forced degradation studies were carried out for Dasatinib under acidic, basic, thermal, reduction and oxidation conditions, among which oxidative degradation and basic degradation had above 90 % and 30 % degradation. The degradation products were characterized by MS-MS. The developed method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug. The recoveries of Dasatinib were found to be within the range.