三层共挤输液袋包装氯化钠注射液中抗氧剂1310的HPLC法测定

HPLC Determination of Irganox 1310 in Sodium Chloride Injection in Three-layer Co-extrusion Bags

建立了高效液相色谱法测定三层共挤输液袋包装的氯化钠注射液中3-（3,5-二叔丁基-4-羟基苯基）丙酸（抗氧剂1310）含量。采用Eclipse C18色谱柱,以乙腈（含0.1%乙酸）∶0.1%乙酸（60∶40）为流动相,检测波长为210 nm。结果抗氧剂1310在0.4~100μg/ml范围内线性关系良好,回收率为94%~106%,RSD小于4%。

An HPLC method was established for the determination of 3-（3,5-di-tert-butyl-4-hydroxyphenyl） propionic acid （Irganox 1310） in sodium chloride injection packaged in three-layer co-extrusion bags. The study was carried out with Eclipse Cl8 column and acetonitrile （containing 0.1% acetic acid） ： 0.1% acetic acid （60 - 40） as mobile phase. The detection wavelength was 210 nm. The results showed that it was linear for Irganox 1310 in the range of 0.4-100 μg/ml. The recoveries were 94%--106% with RSDs less than 4%.