三层共挤输液用袋中抗氧剂1010的降解产物抗氧剂1310在3种pH介质中的提取研究

目的:建立高效液相色谱法测定三层共挤膜输液袋中抗氧剂1010(四[β-(3,5-二叔丁基-4-羟基苯基)丙酸]季戊四醇酯)的降解产物抗氧剂1310(3,5-二叔丁基-4-羟基苯基丙酸)在不同提取介质中的含量的测定方法,研究抗氧剂1310向不同介质的迁移情况。方法:采用C₁₈色谱柱(4.6 mm× 150 mm,5 μm),以乙腈[乙腈-乙酸(1 000:1)]-水[水-乙酸(1 000:1)](60:40)为流动相,流速 1.0 mL·min^-1,检测波长210 nm。结果:抗氧剂1010降解产物抗氧剂1310质量浓度在0.4~100 mg·L^-1范围内线性关系良好,在pH 3.5和pH 8.0缓冲液以及水介质中的回收率均介于86%~103%,RSD小于1.5%。采取6 cm²·mL^-1比例及121 ℃、1 h进行浸提3批样品,在pH 3.5缓冲液和水以及pH 8.0缓冲液介质中分别为0.11~0.15、0.37~0.40和0.61~0.78 mg·L^-1。结论:固相萃取-高效液相色谱法测定抗氧剂1010降解产物抗氧剂1310提取量在不同提取介质中的含量的测定方法准确可靠。

Objective:To establish an HPLC method for the determination of degradation product irganox 1310(3,5-di-tert-butyl-4-hydroxyphenylpropionic acid) from irganox 1010(pentaerythritol tetrakys 3-(3,5-ditert-butyl-4-hydroxyphenyl)propionate) in three extraction medium with different pH from three-layer co-extrusion bag for infusion.Methods:A C₁₈ chromatograph column(4.6 mm×150 mm,5 μm) was used with the mobile phase of acetonitrile [acetonitrile-acetic acid(1 000:1)])-water[water-acetic acid(1 000:1)] (60:40) at the flow rate of 1.0 mL·min^-1.The detection wavelength was 210 nm.Results:The calibration curve was linear between 0.4-100 mg·L^-1,and the recoveries was between 86%-103% with RSD less than 1.5% in three extraction medium.Three batches of sample was extracted by 6 cm²·mL^-1 and 121 ℃,1 h.The concentration in the extracting medium of pH 3.5 buffer,water and pH 8.0 buffer were 0.11-0.15 mg·L^-1, 0.37-0.40 mg·L^-1 and 0.61-0.78 mg·L^-1,respectively.Conclusion:The established SPE-HPLC method is accurate and reliable for the determination of degradation product of Irganox 1010 in three extraction medium with different pH from three-layer co-extrusion bag for infusion.