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目的采用顶空气相色谱法测定奈韦拉平中6种有机溶剂的残留量。方法采用HP-5(30 m×0.32 mm,0.25μm)毛细管柱,程序升温,氢火焰离子化检测器检测,载气为氮气。结果乙醇、丙酮、环丙胺、环己烷、甲苯、二乙二醇二甲醚在考察范围内的线性关系良好(r2≥0.9970),平均回收率为97.9%~101.0%,检测限分别为0.05、0.05、0.15、0.004、0.089、1.5μg·mL-1。结论所用方法灵敏度高、准确度高、重现性好,可用于奈韦拉平中残留溶剂的检查。
Objective To determine the residues of six organic solvents in nevirapine by headspace gas chromatography. Methods HP-5 (30 m × 0.32 mm, 0.25 μm) capillary column was used. The temperature was programmed and hydrogen flame ionization detector was used. The carrier gas was nitrogen. Results The linear relationship between ethanol, acetone, cyclopropylamine, cyclohexane, toluene and diethylene glycol dimethyl ether was good (r2≥0.9970) and the average recovery was 97.9% ~ 101.0% with the detection limits of 0.05 0.05, 0.15, 0.004, 0.089, 1.5 μg · mL -1. Conclusion The method used has high sensitivity, high accuracy and reproducibility and can be used for the determination of residual solvents in nevirapine.