顶空气相色谱法测定紫杉醇中多种残留溶剂

目的建立紫杉醇原料药中有机溶剂残留量的测定方法。方法采用顶空进样毛细管气相色谱法，HP-INNOWax毛细管柱（30m×0，32mm，0．25μm），以氮气为载气，用FID检测器测定紫杉醇原料药中石油醚（60～90℃）、丙酮、四氢呋喃、乙酸乙酯、甲醇、二氯甲烷、甲苯和吡啶的残留量（按外标法计算）。结果8种有机溶剂完全分离，质量浓度在考察范围内与峰面积具有良好的线性关系，r为0．9990～0，9998，平均回收率为93.9％～102.6％，精密度RSD均小于10％，最低检出限为0，02～1．06μg／mL。结论顶空气相色谱法快速、灵敏、准确，可用于紫杉醇中8种有机溶剂残留量的测定。

Determination of Residual Organic Solvents in Paclitaxel by Headspace Gas Chromatography

Objective To establish a method for determination of eight residual organic solvents in paclitaxel. Methods The residual organic solvents in paclitaxel are petroleun ether （60 -90℃ ）, acetone, tetrahydrofuran, ethyl acetate, methonal, dichloromethane, toluene and pyridine. They were quantitatively determined by headspace gas chromatography （GC） on HP-INNOWax column with FID detector, nitrogen as the carries. Results Eight residual solvents were completely separated. There was a good linearity in the experimental concentration （r =0. 999 0- 0. 999 8）.The RSD of precision was less than 10%.The average recovery rate ranged from 93.9% to 102. 6%. The detection limits was between 0.02- 1.06 μg/mL. Conclusion The method appears to be rapid, sensitive and accurate. It can be used for quality control for the determination of eight residual organic solvents in paclitaxel.