用顶空气相色谱法测定西伐他汀中甲苯残留量

Determination of Residual Toluene in Simvastatin by Headspace Gas Chromatography

建立了用顶空ＧＣ法测定西伐他汀中甲苯残留量的方法，选用４０１有机担体作色谱柱，用５０ｇ／Ｌ十二烷基硫酸钠水溶液作溶剂。线性范围为０．５～４．０ｍｇ／Ｌ，ｒ＝０．９９８７；平均回收率为１０３．０６％。该法灵敏度高、简便、准确。甲苯的最低检测限为０．５ｍｇ／Ｌ。

A method for the determination of residual toluene in simvastatin by headspace gas chromatography with a GDX-401 column was established. A 50 g/L sodium dodecyl sulfate solution as solvent of sample was used. The result showed that the linear range of calibration curve was 0.5～4.0 mg/L (r=0.998 7); recovery was 103.06 %(n=3); the detection limit of toluene was 0.5 mg/L. The method is simple, accurate and sensitive.