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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C_(18)色谱柱(4.6 mm×150 mm,5μm),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 m L·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p H 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 cm~2·m L~(-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 a method for the determination of the degradation of antioxidant 1010 pentaerythritol tetrakis [β- (3,5-di-tert-butyl-4-hydroxyphenyl) propionate] Product Antioxidant 1310 (3,5-di-tert-butyl-4-hydroxyphenylpropionic acid) in different extraction media content determination method to study antioxidant 1310 migration to different media. Methods: The mobile phase consisted of acetonitrile - acetonitrile (1000: 1)] - water [water - acetic acid (1000: 1)] (60:40) on a C 18 column (4.6 mm × 150 mm, As mobile phase, the flow rate was 1.0 m L · min ~ (-1) and the detection wavelength was 210 nm. Results: The linear relationship between antioxidant 1010 antioxidant concentration of 1310 and 0.4 -100 mg · L -1 was good, and the recoveries in p H 3.5, pH 8.0 buffer and aqueous medium were good At 86% ~ 103%, RSD is less than 1.5%. Three batches of samples were extracted at 6 cm ~ 2 · m L -1 and 121 ℃ for 1 h, respectively, and were 0.11 ~ 0.15 and 0.37 ~ 0.40 in pH 3.5 buffer and water and pH 8.0 buffer respectively And 0.61 ~ 0.78 mg · L -1. Conclusion: The method for determination of 1310 extraction amount of antioxidant 1010 degradation product in different extraction media by solid phase extraction - high performance liquid chromatography is accurate and reliable.