毛细管气相色谱法测定多西他赛中的残留溶剂

目的：建立气相色谱法测定多西他赛原料药中残留溶剂的方法。方法：采用DB—FFAP弹性石英毛细管柱（30m×0．32mm×0．25μm）；FID检测器；色谱条件：柱温40℃保持5．5min，以20℃·min。的速率升温至220℃，保持5min；进样口温度为220℃；检测器温度为250℃；分流进样，分流比为1：加。结果：7种残留溶剂均呈现较好的线性关系（r=0．9973～0．9996）；平均回收率为94．3％-111．7％。结论：本测定方法简便、准确，可用于多西他赛原料药溶剂残留量的控制。

Determination of Residual Solvents in Docetaxel by Capillary GC

Objective： To establish a Capillary GC method for determination the residual solvents in Docetaxel. Method： DB - FFAP capillary column（30 m × 0.32 mm × 0.25 μm） was used, the detector was FId, initial column temperature was kept at 40 ℃for 5.5 min, then rose to 220℃ with an increase rate of 20 ℃ min -1, and maintained for 5 min. Injector temperature was set at 220℃ and detector at 250 ℃ respectively. Split ratio was 1 ： 20. Result ： The calibration curves of residnal solvents in Docetaxel showed a good linearity（r = 0.9697 3 - 0. 999 6）, the average recovery was 94.3% - 111.7%. Conclusion ： The method is simple and accurate, it can be used for the control of the residual solvents in Docetaxel.