气相色谱法测定艾司奥美拉唑钠中3种残留溶剂

摘要

建立艾司奥美拉唑钠中残留溶剂的测定方法.采用气相色谱法,DB-FFAP色谱柱(30 m×0. 530 mm 3. 00 μm), FID 检测器,载气为氮气,程序升温;进样口温度290 ℃,检测器温度300 ℃;按外标法计算结果.各成分在考察的浓度范围内有良好线性关系,3种成份回收率均在95.0% ~105.0%之间.精密度RSD均<1.0%.所建方法专属性强,灵敏度高,结果可靠,可用于艾司奥美拉唑钠中3种残留溶剂的同时测定.%A method for determination of three residual solvents in esomeorazole sodium was established. Gas Chromatography was used for determination of residue solvents. DB-FFAP capillary column (30 m×0. 530 mm 3. 00 μm) was used with FID as detector and nitrogen as carrier gas. The amount of residul solvents can be calculated through outnal standard method. Good linearity was obtained in the experimental concentration range. The recoveries were in the range of 95.0% ~105.0%. The RSDs were all less than 1.0%. The method is specific,sensitive,simple and credible, which can be used for determination of three residual solvents in esomeprazole at the same time.