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目的建立硫酸特布他林中甲醇、乙醇、丙酮、甲基叔丁基醚、乙酸乙酯、四氢呋喃、苯、乙酸、甲苯和氯化苄共10种有机溶剂残留量的测定方法。方法采用顶空气相色谱法,色谱柱为DB-624UI毛细管柱(30 m×0.32 mm,1.80μm),柱温采用程序升温;进样口温度为200℃;检测器为氢火焰离子化检测器,检测器温度为250℃,溶剂为体积分数为70%二甲基甲酰胺。结果 10种溶剂完全分离;在考察的质量浓度范围内线性关系良好,相关系数r>0.999 4,平均回收率为95.7%~102.4%。结论建立的顶空气相色谱法可用于硫酸特布他林中残留溶剂的测定。
Objective To establish a method for the determination of 10 organic solvents in terbutaline sulfate, including methanol, ethanol, acetone, methyl tert-butyl ether, ethyl acetate, tetrahydrofuran, benzene, acetic acid, toluene and benzyl chloride. Methods The column was DB-624UI capillary column (30 m × 0.32 mm, 1.80 μm) with headspace gas chromatography. The temperature of the column was raised by programmed temperature. The inlet temperature was 200 ℃. The detector was hydrogen flame ionization detector , The detector temperature is 250 ℃, the volume fraction of solvent is 70% dimethylformamide. Results The 10 solvents were completely separated. The linearity was good within the investigated mass concentration range. The correlation coefficient r was 0.999 4 and the average recovery was 95.7% -102.4%. Conclusion The established headspace gas chromatography can be used for the determination of residual solvents in terbutaline sulfate.