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目的建立微波萃取-高效液相法测定塑料输液包装材料与容器中抗氧剂1010、抗氧剂330、抗氧剂1076、抗氧剂168的含量,并考察抗氧剂在注射液中的迁移情况。方法以抗氧剂含量为测定指标,采用正交试验法,通过统计学分析确定最佳提取工艺条件。采用Sunfire-C18(4.6 mm×150 mm,5μm)色谱柱;流动相:乙腈-四氢呋喃-水(6∶3∶1);流速:1.5 mL·min-1;柱温:40℃;检测波长:280 nm;进样量:20μL。结果最佳微波萃取条件为取样量2 g,100℃提取30 min。抗氧剂1010、抗氧剂330、抗氧剂1076、抗氧剂168在质量浓度0.004~0.5 mg·mL~(-1)内具有良好的线性关系(r=0.999 9),平均回收率在96.8%~103.7%,RSD均小于2%(n=9)。结论本方法方便、灵敏、可靠,可用于塑料输液袋中抗氧剂的含量及其迁移量的测定。
OBJECTIVE To establish a microwave extraction - high performance liquid phase method for the determination of antioxidant 1010, antioxidant 330, antioxidant 1076, antioxidant 168 in plastic infusion packaging materials and containers, and investigate the migration of antioxidants in the injection Happening. Methods Antioxidant content was taken as the measurement index. The orthogonal experiment method was adopted to determine the optimum extraction process conditions by statistical analysis. The mobile phase was acetonitrile-tetrahydrofuran-water (6: 3: 1); the flow rate was 1.5 mL · min-1; the column temperature was 40 ℃; the detection wavelength was: 280 nm; injection volume: 20 μL. Results The optimum microwave extraction conditions were 2 g sample volume and 100 min extraction time for 30 min. Antioxidant 1010, antioxidant 330, antioxidant 1076 and antioxidant 168 had a good linear relationship (r = 0.999 9) within the range of 0.004-0.5 mg · mL -1. The average recovery was 96.8% ~ 103.7%, RSD less than 2% (n = 9). Conclusion The method is convenient, sensitive and reliable, and can be used to determine the content of anti-oxidant and its migration in plastic infusion bag.