气相色谱测定香兰素标准物质中乙醇残留方法学研究

Determination of Residual Ethanol in the Vanillin Standard Substance by Gas Chromatography

目的建立了一种香兰素中残留有机溶剂乙醇含量的气相色谱方法.方法采用气相色谱法对香兰素中乙醇的含量进行了测试;并参照《中国药典》;2010版附录中XIXA和有机溶剂残留的指导原则对测定方法精确性、准确度等方面进行了评价.结果线性和范围：o.0107～0.1495mg/mL,R=0.9995;重复性：SD（％）=0.61％,平均回收率99.42％;稳定性：样品在12h内主峰面积稳定,RSD（％）=0.88％;耐用性：检测器、进样口温度、柱温在温度上波动士5℃对测试影响较小.绪论经方法学验证,该法简便快捷灵敏度高结果准确,适用于香兰素中乙醇的检测.

Objective： To establish a quantitative method for determination of ethanol in vanillin certified reference material. Methods： Determination of ethanol in reference material of vanillin by capillary gas chromatography. Method for determination of the residual organic solvent base on Chinese pharmacopoeia 2010 edition. Results： linely： 0.0107-0.1495 mg/mL, R2=0.9995; Iteration： SD（%）= 0.61%; Recovery： 99.42 %; RSD（%）=0.88 %; stability： 12 h; durability： 250±5 ℃. Conclusion： The method is simple, rapid, sensitive and accurate. It is suitable for the content determination of residual ethanol in vanillin.