摘要
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-HPLC method for determination of antioxidant 1010, antioxidant 330, antioxidant 1076, and antioxidant 168 in plastic infusion packaging materials and containers, and investigate the migration of the antioxidants from the materials to the injection. METHODS Taking the contents of antioxidants as indices, the best extraction condi- tion was determined with or thogonal experiments and statistical analysis. The separation of antioxidants was performed on a Sunfire-C18 （4. 6 mm × 150 mm,5 μm） chromatographic column at 40 ℃ , and the detection wavelength was set at 280 nm. The mobile phase con- sisted of acetonitrile, tetrahydrofuran, and water （6： 3：1 ） at a flow rate of 1.5 mL. min-1, and the injection volume was 20 μL. RE- SULTS The optimized extraction process was extracting 2 g of sample at 100 ℃ for 30 min. The calibration curves of antioxidant 1010, antioxidant 330, antioxidant 1076, and antioxidant 168 were linear over the concentration range from 0. 004 to 0. 5 mg . mL-1 （r = 0. 999 9） and the average recoveries of the anti oxidants ranged from 96. 8 % to 103.7% （RSD 〈 2%, n = 9 ）. CONCLUSION This method is convenient, sensitive, and reliable and it can be used for the determination of antioxidants in plastic infusion materials and their migration to the injection.
作者
李樾
孙会敏
张烜
LI Yue SUN Hui-min ZHANG Xuan(Pharmaceutical Sciences, Peking University School, Beijing 100191, China National Institutes for Food and Drug Control, Beijing 100050, China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2016年第19期1699-1705,共7页
Chinese Pharmaceutical Journal
