Novel HPLC Method for Determination of Process Related Impurities of Dasatinib Drug Substance

A simple and sensitive reverse phase liquid chromatography (RP-HPLC) method has been developed for the determination of process related impurities of Dasatinib drug substance. Separation was achieved with a Inertsil ODS 3V, (Make GL Sciences), 150mm x 4.6mm, particle size 5m column and buffer was prepared by dissolving 1.36g of potassium dihydrogen phosphate and 1.0g of sodium-1-octane sulphonic acid into 1000ml water, dissolve and adjust pH 6.0 with dilute potassium hydroxide solution. The flow rate was set 1ml/minute and the column temperature was 50C. UV detection was performed at 315nm and injection volume 20L with ambient sample temperature. The method is simple, rapid, and specific. The method is suitable for the determination of almost all process related impurities of Dasatinib drug substance. The method is useful for the determination of following impurities. a) KSM-01 (Key starting material 2-Amino-N- (2-chloro-6-methylphenyl) thiazole-5-carboxamide) b) DAS-01 (N- (2-Chloro-6-methylphenyl) -2- [ (6-chloro-2-methyl-4-pyrimidinyl) amino]-5 thiazole carboxamide) c) Dimer of DAS-01 d) N-Oxide dasatinib e) N-Deshydroxyethyl dasatinib f) Dimer of dasatinib drug substance