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Rapid and Sensitive RP-HPLC Method for Determination of Potential Genotoxic Impurity in Dasatinib Drug Substance

Sunil V Lanke, Sajid Syed Shahnawaz, Dhramveer Singh Shekhawat, Nishikumar Niture, Radhiah Che Rusli, Nurul Syazwani Nadirah and Mohd Zulfadli Makhtar

A simple and sensitive reverse phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of potential genotoxic carboxamide [2-Amino-N-(2-chloro-6-methylphenyl) thizaole-5-carboxamide] impurity at trace level in Dasatinib drug substance. Separation was achieved with a Inertsil C8-3, (Make: GL Sciences); 150 × 4.6 mm I.D; particle size 5 μm column and buffer was prepared by dissolving 1.36 g of potassium dihydrogen phosphate into 1000 ml water; and pH adjusted to 6.0 with dilute potassium hydroxide solution. The flow rate was set 1 ml/min and the column temperature was 40°C. UV detection was performed at 299 nm and injection volume 20 μL with ambient sample temperature. The method is simple, rapid, and specific. The described method is linear, precise and accurate over a range of 1.5 μg/mL to 20.0 μg/mL. The method precision for the determination of genotoxic carboxamide impurity was below 2.0% RSD. The percentage recoveries of genotoxic carboxamide impurity ranged from 95% to 113%. It can be conveniently adopted for routine analysis of determination of genotoxic carboxamide impurity in Dasatinib drug substance.