中文摘要：

目的用毛细管柱气相色谱法建立索拉非尼中5种残留溶剂的测定方法。方法采用DB-Wax（30m×0.45mm,0.85μm）毛细管柱,载气为氮气,FID检测器。采用程序升温,柱温：40℃,保持5min,然后以15℃/min的速率升至200℃。进样口温度：220℃,检测器温度：250℃,分流直接进样,N,N-二甲基甲酰胺为溶剂,丙酮为内标物,内标法计算残留溶剂的含量。结果在考察的浓度范围内呈现良好的线性关系（正庚烷r=0.9995、乙酸乙酯r=0.9993、甲醇r=0.9998、异丙醇r=0.9991、甲苯r=0.9997）,平均回收率为96%～104%,理论塔板数均大于10000,相邻峰的分离度均大于2,精密度、重复性RSD均小于3%。结论本法简单,结果准确,重复性好,适用于索拉非尼中正庚烷、乙酸乙酯、甲醇、异丙醇和甲苯5种残留溶剂的同时检测。

英文摘要：

Objective To establish a method for determining the residues of 5 kinds of solvents in sorafenib by capillary gas chromatography. Methods The capillary column was DB-Wax（30 m×0.45 mm,0.85 μm） with an FID detector and nitrogen as carrier gas. The injector temperature and the detector temperature were controlled at 220℃ and 250℃, respectively. The column temperature program was initially 40℃（hold 5 min） and increased at the rate of 15℃/min to 200℃, The sample was dissolved in N,N-dimethylformamide and acetone was used as the internal standard. The assay of residual solvents was calculated by internal standard method. Results A good linearity was observed at the experimental concentration （r： 0.9991-0.9998）. The rate of recovery was in the range of 96%-104%. The number of theoretical plates ecceeded 10 000 and the resolutions between the adjacent peaks were more than 2. The RSD of precision and accuracy was less than 3%. Conclusion The method is simple, sensitive, accurate, and can be used for detection of five residual solvents in sorafenib.