毛细管柱气相色谱法测定七氟烷的有关物质

Determination of related substances of sevoflurane by capillary gas chromatography

目的建立毛细管气相色谱法测定七氟烷的有关物质。方法本文采用毛细管气相色谱法,程序升温,FID检测器,色谱柱为DM-624毛细管柱（以6%氰丙苯基-94%二甲基聚硅氧烷为固定相;75 m×0.53 mm,3.0μm）,对七氟烷合成工艺中存在的已知杂质戊氟异丙基氟甲醚和己氟异丙基甲基醚及未知杂质都进行了很好的分离和测定。结果七氟烷杂质含量测定的线性范围为0.14~0.72μg/mL,回归方程：Y=4.269X-0.041 3（r=0.999 6）。最低检测限为6.272 ng,精密度RSD为1.88%。结论本法专属性强,灵敏度高,结果准确,可用于七氟烷的有关物质检查。

Objective To establish a method for determination of related substances of sevoflurane by capillary gas chromatography.Methods The determination was performed on a DM-624 capillary column（coated with cross-linked 6% Polycyanopropylphenylsiloxane and 94% Polydimethylsiloxane,75 m×0.53 mm,3.0 μm）,using temperature programming,with FID detector.The known impurities and unknown impurities in the synthesis process of sevoflurane were separated very well.Results There was a linear relationship in the concentration range of 0.14-0.72 μg/mL,the regression equation was Y = 4.269X-0.041 3（r = 0.999 6） with the correlation coefficient of 0.999 6.The limit of detection was 6.272 ng and the relative standard deviation（RSD） value for precision was 1.88%.Conclusion This method is validated to be specific,accurate and suitable for the measurements of sevoflurane and its related substances.