Abstract：In this article we established the quality control standard of Bicalutamide. The methods of content determination which we have adopted were as follows: Alltima column（150×4.6mm，5μ，Alltech）,and the mobile phase consisted of a mixture of acetonitrile and water buffer solution (47:53) pumped at a flow rate of 1.0mL/min. The detection wavelength was 270nm. The methods of content determination was simple，specific and accurate. It can be used for the quality control of Bicalutamide. In destroying experiments of related substance measure item, the samples were destroyed by acid, alkali, oxidation, heating and illumination. The related substance can be separated from Bicalutamide, which showed this chromatographic system being effective. In organic residual solvents measure item, we used headspace GC chromatography to examine ethanol, trichloroethane, aether, dichloromethane, tetrahydrofuran, toluene, chloroform, ethyl acetate, petroleun ether, DMF and DMAC residue in Bicalutamide. DMF was used as solution. Sample had been equilibrated at 80℃ for 30min. HP-5（0.32mm×30m×0.22μm）capillary column was used. The temperature of injector, FID and column were 200℃., 200℃.and 50℃ respectively. We have done other experiments according to Chinese Pharmacopoeia. Finally, we have written quality standard of Bicalutamide in Chinese Pharmacopoeia’s formats.
Keywords：Bicalutamide; Quality standard; Test of impurities；Quality control
