【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。更多还原

【Abstract】 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.更多还原