METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CLASS II SLOVENTS IN DASATINIB BY HSGC-FID

*Fayeza Ameen, Dr. V. Murali Balaram and Dr. Anupama Koneru

ABSTRACT

A simple and selective HS-GC method is described for the determination & quantification of Residual solvents in Dasatanib API. Chromatographic separation was achieved on aDB-624 column, (50mx0.22mm) 1.8μmusing different temperature gradient of FID Detectors. Linearity was observed in the range 50-150 μg /ml for Acetonitrile, Toulene, Methylene Chloride, Dimethyl formamide and n-hexane (r2>0.999) forsolvent estimated in by the proposed methods was in good agreement. These methods were validated. Recovery experiments indicated the absence of interference from commonly encountered diluent and API. This method is precise as indicated by the repeatability analysis, showing %RSD less than 10 for Acetonitrile, Toulene, Methylene Chloride, Dimethyl formamide and n-hexane. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical active ingradients to Estimation of Residual solvents of Acetonitrile, Toulene, Methylene Chloride, Dimethyl formamide and n-hexane in Dasatanib.

Keywords: Dasatinib, HS-GC, FID Detectors, Residual solvents.