Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF GENOTOXIC IMPURITY DSN-V IN DASATINIB

Govinda Rao Kamala*, Sathish Kumar Konidala, Vinod Kumar Mugada, Sravani Koralla and Nithin Bommareddy.

ABSTRACT

A RP- HPLC method was developed for the estimation of DSN-V (2-Aminothiazole-n-(2-chloro-6-methylphenyl)-5-carboxamide) in Dasatinib. The DSN-V is a potential genotoxic impurity and need to be controlled in Dasatinib. The analysis was performed using HYPERSIL BDS C-18 (250x4.6mm, 5um) column as stationary phase and mobile phase gradient elution technique using 10Mm Formic acid +0.1%formic acid buffer (Mobile phase A), Acetonitrile and methanol in the ratio 2:3 (mobile phase B). The UV detector was used for quantification. the retention times for DSN-V and Dasatinib were found to be 6.61 min and 12.26 min respectively. The calibration curves showed good linearity over the concentration range of 9 ng/ml to 75ng/ml. The correlation coefficient was found to be 0.999. Excellent recoveries were obtained at 50, 100 and 150 % levels. The proposed method was cost effective, specific, linear, accurate, rugged and precise.

Keywords: Dasatanib; DSN-V; Gradient technique; RP-HPLC; Genotoxic impurity.


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