0.9%氯化钠注射液中两种酯类阻氧剂的测定

目的用高效液相色谱法测定聚丙烯包装的0.9%氯化钠注射液中两种酯类阻氧剂(1010和168)的含量,研究工业阻氧剂向制剂中浸出情况。方法采用C18柱(250 mm×4.6 mm)为色谱柱;乙腈-乙醇-四氢呋喃(61∶10∶29)为流动相;流速:1.5 ml·min-1;紫外检测器检测波长:275 nm;结果阻氧剂1010在0.6～240 mg·L-1范围内线性关系良好,平均回收率为88.43%,RSD=3.90%;阻氧剂168在1.2～240 mg·L-1范围内线性关系良好,平均回收率为91.27%,RSD=3.57%。结论在0.9%氯化钠注射液中存在包装材料中的阻氧剂,需要加强控制,该法简便、有效,可以用来对阻氧剂定量。

Determination of antioxidant 1010 and antioxidant 168 contained in 0.9%sodium chloride injection by HPLC

Aim To establish an HPLC method for determination of antioxidant 1010 and antioxidant 168 contained in 0.9%sodium chloride injection.Methods The determination was carried out by using an elite C18 column（250 mm×4.6 mm） with ethanol-tetrahydrofuran-acetonitrile（10∶ 29∶ 61） as mobile phase.The UV detection wavelength was 275 nm and the flow rate was 1.5 ml·min^-1.Results Under the chromatographic conditions used,there were no interferences found in the positions of antioxidant 1010 peak and antioxidant 168 peak.Antioxidant 1010 and antioxidant 168 had good linear responses（r= 0.999 9） in the concentration ranges of 0.6-240 mg·L^-1 and 1.2-240 mg·L^-1 respectively.The average recoveries of antioxidant 1010 and antioxidant 168 in 0.9%Sodium Chloride Injection were 88.43% with the relative standard deviation of 3.90 % and 91.27% with the relative standard deviation of 3.57% respectively.Conclusions There are antioxidant 1010 and antioxidant 168 in the 0.9%Sodium Chloride Injection.It is necessary to control the quantity of antioxidant 1010 and antioxidant 168 in the 0.9%Sodium Chloride Injection.The method employed in this analysis is reliable and convenient with good repetition and can be used for quality control in the production of 0.9%Sodium Chloride Injection.