葡萄糖氯化钠注射液中抗氧剂168降解产物的HPLC法测定  

Determination of 2,4-di-tert-butyl-phenol in glucose and sodium chloride injection

作　　者：沈丹霞 蔡荣 张芳芳 王蓉佳 

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《药物分析杂志》2017年第11期2053-2056,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC测定葡萄糖氯化钠注射液(250 m L:葡萄糖12.5 g与氯化钠2.25 g)中2,4-二叔丁基苯酚(168降解产物)含量测定方法。方法:采用Eclipse C_(18)色谱柱,以乙腈-水(70∶30)为流动相,检测波长为210 nm。结果:抗氧剂168降解产物0.1~50μg·m L^(-1)范围内线性关系良好,回收率为94%~100%,RSD小于0.8%。样品实测结果均小于0.01μg·m L^(-1)。结论:固相萃取-高效液相色谱法测定抗氧剂168降解产物在葡萄糖氯化钠注射液中含量的测定方法准确可靠。Objective： To establish an HPLC method for the determination of 2,4-di-tert-butyl-phenol （ degradation product of antioxidant 168 ）in glucose and sodium chloride injection （ 250 mL： glucose 12.5 g/sodium 2.25 g ）. Methods：The study was carried out with Eclipse C18 column and acetonitrile： water（ 70：30 ）as mobile phase. The detection wavelength was 210 nm. Results：The results showed that it was good linearity for 2,4-di-tert- butyl-phenol in the range of 0. 1-50 μg· mL-1. The recoveries were 94%-100% with RSDs less than 0.8%. The measured results of the samples were less than 0.01 μg. mL-1. Conclusion： The established SPE-HPLC method is useful for the determination of degradation product of Irganox 168 in glucose and sodium chloride injection.

关 键 词：葡萄糖氯化钠注射液 抗氧剂168降解产物 HPLC 相容性 药包材 

分 类 号：R917[医药卫生—药物分析学]