顶空气相色谱法测定吐温80中的环氧乙烷与二氧六环  

Determination of ethylene oxide and dioxane in Tween 80 by HS-GC

作　　者：李炎[1,2] 晁若冰[1] 李睿 邹剑 张帆 

机构地区：[1]四川大学华西药学院,四川成都610041 [2]四川省食品药品检验检测院,四川成都610097 [3]成都蓉生药业有限责任公司,四川成都610041

出　　处：《华西药学杂志》2014年第6期704-705,共2页West China Journal of Pharmaceutical Sciences

摘　　要：目的改进《中国药典》2010年版中吐温80项下环氧乙烷与二氧六环残留量的检查方法。方法采用DB-624毛细管柱（30 m×0.32 mm,1.8μm）,程序升温,氢火焰离子化检测器,顶空瓶各溶液中均加入50μL 1 mol·L-1的Na OH,采用标准加入法定量。结果环氧乙烷、二氧六环的回归方程分别为：Y1=2.763X＋0.6834（r=0.9998）、Y2=47.222X＋0.9331（r=0.9937）,平均回收率分别为100.7%、95.3%,RSD分别为4.74%、3.97%（n=9）。环氧乙烷0.901-28.454μg·m L-1、二氧六环12.89-95.31μg·m L-1与峰面积的线性关系良好。结论改进后的方法简单、准确、可靠,可用于吐温80中环氧乙烷、二氧六环的测定。OBJECTIVE To improve the HA- GC method for the determination of ethylene oxide and dioxane in Tween 80 by HS-GC in Chinese Pharmacopoeia 2010. METHODS HS- GC,FID detector and DB- 624 capillary column（ 30 m × 0. 32 mm,1. 8 μm）was used and the column temperature was programmed raised. The solvent was water（ 50 μL 1 mol·L- 1sodium hydroxide solution was added）. The ethylene oxide and dioxane were quantified by standard addition method. RESULTS The regression equation correlations of ethylene oxide and dioxane were Y1= 2. 763 X ＋ 0. 6834（ r = 0. 9998） and Y2= 47. 222 X ＋ 0. 9331（ r = 0. 9937）,respectively. The average recoveries were 100. 7% and 95. 3%,and the RSD were 4. 74% and 3. 97%（ n = 9）,respectively. The linearity ranges were0. 901- 28. 454 μg·m L- 1and 12. 89- 395. 31 μg·m L- 1,respectively. CONCLUSION This improved method is convenient and quick for the quantitative determination of the ethylene oxide and dioxane,and can be used for the quality control.

关 键 词：吐温80 顶空气相色谱法 环氧乙烷 二氧六环 

分 类 号：R917[医药卫生—药物分析学]