GC测定艾司奥美拉唑钠中2-苯基-2-丙醇残留量  

Determination of Residual 2-Phenyl-2-Propanol in Esomeprazole Sodium Bulk Drug by GC

作　　者：杨帅 张治云 YANG Shuai;ZHANG Zhi-yun(Shandong Academy of Pharmaceutical Sciences,Jinan 250101,China)

机构地区：[1]山东省药学科学院,山东济南250101

出　　处：《食品与药品》2021年第4期363-365,共3页Food and Drug

摘　　要：目的建立气相色谱(GC)测定艾司奥美拉唑钠原料药中2-苯基-2-丙醇残留量的方法。方法色谱柱为安捷伦DB-624毛细管柱,程序升温,进样口温度为230℃,检测器为氢火焰离子化检测器,检测器温度为250℃。结果2-苯基-2-丙醇浓度在5~100μg/ml范围内与峰面积线性关系良好(r=0.9999),平均回收率为101.11%(RSD=1.82%)。结论本法专属性强、重复性好、灵敏度高,可用于艾司奥美拉唑钠原料药中2-苯基-2-丙醇残留量测定。Objective To establish a method for determination of residual 2-phenyl-2-propanol in esomeprazole sodium bulk drug by GC.Methods The determination was performed on an Agilent DB-624 capillary column with temperature programming.The inlet temperature was 230℃,and hydrogen flame ionization detector was adopted with the temperature of 250℃.Results A good linear relationship was obtained in the concentration rang of 5-100μg/ml for 2-phenyl-2-propanol,with the correlation coefficient of 0.9999.The average recovery was 101.11%(n=9),with RSD of 1.82%.Conclusion The method has good specificity,repeatability and high sensitivity.It can be used for determination of residual 2-phenyl-2-propanol in esomeprazole sodium bulk drug.

关 键 词：气相色谱 艾司奥美拉唑钠 2-苯基-2-丙醇 

分 类 号：R917[医药卫生—药物分析学]