气相色谱法测定依折麦布中硫酸二异丙酯的含量  

Determination of Diisopropyl Sulfate in Ezetimibe by GC

作　　者：杨琪 刘延新 杨海霞 邢玉仁 

机构地区：[1]山东省药学科学院山东省生物药物重点实验室,济南250101 [2]山东福瑞达医药集团公司山东省黏膜与皮肤给药技术重点实验室

出　　处：《中国药师》2016年第4期774-776,共3页China Pharmacist

基　　金：国家"重大新药创制"科技重大专项(编号:2009ZX09301-013)

摘　　要：目的:建立依折麦布中硫酸二异丙酯的含量测定方法。方法:采用气相色谱法,色谱柱:DB-FFAP毛细管柱(30 m×0.32 mm,0.5μm);检测器:氢火焰离子化检测器(FID);载气:氮气;流速:2.0 ml·min^(-1);升温程序:初始温度为40℃,以25℃·min^(-1)的速度升至180℃,保持2 min。结果:硫酸二异丙酯在4.040~13.466μg·ml^(-1)浓度范围内线性关系良好,r为0.999 8;平均回收率为97.57%,RSD为2.37%(n=9)。结论:本法专属性强、重现性好、灵敏度高,可用于依折麦布中硫酸二异丙酯的含量测定。Objective： To establish a method for the determination of diisopropyl sulfate in ezetimibe. Methods： Diisopropyl sulfate was determined by GC with a DB-FFAP capillary column（ 30 m×0.32 mm,0.5 μm） and an FID. The carrier gas was nitrogen and the flow rate was 2.0 ml·min^（-1）. The temperature program was as follows： the initial column temperature was 40 ℃,and then raised to180 ℃ at a rate of 25 ℃ ·min^（-1）,and maintained for 2 min. Results： Diisopropyl sulfate had a good linear relationship within the range of 4.040-13.466 μg·ml^（-1）（ r= 0.999 8）. The average recovery was 97.57%and RSD was 2.37%（ n= 9）. Conclusion： The method is specific and reproducible with high sensitivity,which can be used to determine the content of diisopropyl sulfate in ezetimibe.

关 键 词：气相色谱法 硫酸二异丙酯 依折麦布 含量 

分 类 号：R927.2[医药卫生—药学]