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.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2014年第6期704-705,共2页
West China Journal of Pharmaceutical Sciences
