利福霉素钠注射液中环氧丙烷、二甘醇测定方法的研究  

Determination of propylene oxide and diethylene glycol in rifamycin sodium injection by GC

作　　者：姚兰[1] 刘杨[1] 张亚杰[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国抗生素杂志》2014年第1期49-51,70,共4页Chinese Journal of Antibiotics

摘　　要：目的建立利福霉素钠注射液中环氧丙烷与二甘醇的测定方法。方法采用气相色谱法，聚乙二醇为固定液的毛细管柱为色谱柱，程序升温，进样口温度为230℃；检测器为氢火焰离子化检测器（FID），检测器温度为250℃；载气为氮气，柱流量1．1mL／min；分流比为20：1。结果2种杂质在所考察的浓度范围内具有良好的线性，线性范围：环氧丙烷0．00166～0．0332mg／mL，r=0．9982；一缩二乙二醇0．00215-0．0430mg／mL，r=0．9999。平均回收率分别为100．3％、98．2％。定量限分别为环氧丙烷0．376μg／mL，一缩二乙二醇2．12gg／mL。结论方法准确可靠，适用于利福霉素钠注射液中环氧丙烷、一缩二乙二醇杂质的测定。Objective To establish a GC method for the determination of propylene oxide and diethylene glycol in rifamycin sodium injection. Methods The GC was equipped with hydrogen flame-ionazition detector, the detector temperature was 250~C, the inlet temperature was 230℃. Temperature programming and the capillary chromatographic column coated with polyethylene glycol was used in the test, the carrier gas was nitrogen, the column flow was 1. 1 mL/min; and the split ratio was 20：1. Results The 2 kinds of impurities had a good linear relation in the range of 0.00166-0.0332mg/mL, r=0.9982 （propylene oxide） and 0.00215-0.04300mg/mL, r=0.9999 （diethylene glycol）. The everage recovery was 100.3% and 98.2% and the quantitative limits were 0.376 and 2.12μg/mL, respectively. Conclusion The method was accurate and reliable, suitable for determination of impurities of propylene oxide and diethylene glycol in rifamycin sodium injection.

关 键 词：二甘醇 环氧丙烷 GC 利福霉素钠注射液 

分 类 号：R927.1[医药卫生—药学]