HPLC法同时测定3种材质药用塑料瓶中5种抗氧剂含量  

Simultaneous determination of 5 kinds of antioxidants in 3 kinds of medicinal plastic bottles by HPLC

作　　者：饶艳春 熊炜 朱碧君 RAO Yanchun;XIONG Wei;ZHU Bijun(Jiangxi Province Engineering Research Certer of Drug and Medical Device Quality,Jiangxi Institute for Drug Control,Jiangxi Province,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心

出　　处：《中国医药导报》2019年第25期27-31,共5页China Medical Herald

基　　金：江西省食品药品监督管理局科研项目(2017YX10);国家药典委员会药品医疗器械审评审批制度改革专项课题(ZG2017-6-02)

摘　　要：目的建立分别以聚丙烯、聚乙烯、聚酯为原料制成的药用塑料瓶中抗氧剂BHT、1010、330、1076、168的高效液相色谱测定法。方法采用Agilent Eclipse XDB-C18(250 mm×4.6 mm,5μm)色谱柱,甲醇-水(梯度洗脱)为流动相,流速为1.0 mL/min,检测波长为278 nm,柱温30℃。结果抗氧剂BHT、1010、330、1076、168在4.969~49.69 mg/L、5.080~50.08 mg/L、4.994~49.94 mg/L、5.014~50.14 mg/L、4.994~49.94 mg/L范围内与峰面积呈良好的线性关系,r值均大于0.999,不同厂家生产的药用塑料瓶检出抗氧剂1010、330、1076、168,含量分别为31.58~203.82μg/g、97.26μg/g、56.15~214.45μg/g、44.68~265.09μg/g。结论该方法操作简便,结果准确,可用于同时测定3种材质药用塑料瓶中5种抗氧剂的含量。Objective To establish a method for the determination of antioxidant BHT, 1010, 330, 1076 and 168 in medicinal plastic bottles made from polypropylene, polyethylene and polyester by high performance liquid chromatography. Methods Agilent Eclipse XDB-C18 (250 mm×4.6 mm, 5 μm) column was used as the column, methanol-water was used as the mobile phase of the gradient elute, with the detection wavelength of 278 nm and the flow rate of 1.0 mL/min. The colomn temperature maintained at 30℃. Results The antioxidant BHT, 1010, 330, 1076 and 168 in the range of 4.969-49.69 mg/L, 5.080-50.08 mg/L, 4.994-49.94 mg/L, 5.014-50.14 mg/L and 4.994-49.94 mg/L showed good linear relationship with the peak area (r > 0.999). The average contents of antioxidant 1010, 330, 1076 and 168 were respectively 31.58-203.82 μg/g, 97.26 μg/g, 56.15-214.45 μg/g and 44.68-265.09 μg/g in the plastic bottles for medicinal use produced by different manufacturers. Conclusion The method is simple and accurate, and it can be used to simultaneously determine the content of 5 kinds of antioxidants in 3 kinds of medicinal plastic bottles.

关 键 词：高效液相色谱法 塑料 抗氧剂 含量测定 

分 类 号：R987[医药卫生—药品]