顶空气相色谱法测定紫杉醇原料药中的有机溶剂残留量

目的建立用顶空气相色谱法测定紫杉醇原料药中的残留溶剂。方法采用顶空气相色谱法,以DB-624毛细管柱(30m×0.53mm×1.8μm)为色谱柱,以氮气为载气,用FID检测器同时测定紫杉醇原料药中的甲醇、丙酮、乙酸乙酯和正庚烷含量。结果这4种有机溶剂被完全分离,各溶剂的线性关系、精密度、回收率和灵敏度均达到了预定的分析要求。结论该方法快速、灵敏、准确,可用于紫杉醇原料药中有机溶剂残留量的测定。

Determination of residual organic solvents in paclitaxel by headspace gas chromatog-raphy

Objective To determine 4 kinds of residual solvents (methanol ,acetone ,ethyl acetate ,and n-heptane) in paclitaxel by headspace gas chromatography (GC) .Methods The residual solvents were determined by headspace capillary GC and separated with a FID DB-624 capillary column (30 m × 0 .53 mm × 1 .8μm) .The carrier gas was nitrogen .Results Under the chromatograph-ic conditions ,the 4 residual organic solvents were completely separated and the linearity ,accuracy ,precision and sensitivity of the 4 organic solvents met the authorized requirements .Conclusion The method is rapid and accurate ,and can be used to determine the 4 kinds of residual organic solvents in paclitaxel .