药品包装材料用塑料粒料中8个常用抗氧剂的含量测定  

Determination of 8 kinds of commonly used antioxidants in pharmaceutical packaging plastic pellets

作　　者：蔡心怡 王悦雯 冯靖 刘言 CAI Xin-yi;WANG Yue-wen;FENG Jing;LIU yan(Tianjin Institute for Drug Control,Tianjin 300070,China)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《药物分析杂志》2020年第3期523-528,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立可同时测定药品包装材料用塑料粒料中8个常用抗氧剂(抗氧剂245、抗氧剂1178、抗氧剂264、抗氧剂3114、抗氧剂1010、抗氧剂330、抗氧剂1076、抗氧剂168)的含量测定方法,并对市售的多家药包材生产企业所使用的塑料粒料中的抗氧剂含量进行考察。方法:以乙腈为提取溶剂,利用高效液相色谱法对塑料粒料中的抗氧剂含量进行测定,色谱柱为Diamonsil C18(150 mm×4.6 mm,5μm),流动相为乙腈-水,梯度洗脱,流速1.5、1.8 mL·min-1,检测波长224 nm。结果:本方法可快速有效地分离测定8个常用抗氧剂。各抗氧剂在相应的浓度范围内线性关系良好,回收率符合要求。通过收集25种不同来源塑料粒料,并测定其中的抗氧剂含量,汇总后便于日后进行药包材原料的选择。结果检测出抗氧剂1178、抗氧剂264、抗氧剂1010、抗氧剂330、抗氧剂1076、抗氧剂168含量范围分别为0.012%~0.046%、0%~0.016%、0.002%~0.012%、0.003%~0.086%、0.007%~0.081%、0.006%~0.057%。结论:本文建立的塑料粒料中抗氧剂的检测方法简便,准确,可用于考察塑料粒料中8个常用抗氧剂的含量及质量控制。Objective:To establish a method for simultaneous determination of 8 kinds of commonly used antioxidants(antioxidant 245,antioxidant 1178,antioxidant 264,antioxidant 3114,antioxidant 1010,antioxidant 330,antioxidant 1076,antioxidant 168)in pharmaceutical packaging plastic pellets and to inspect the content of antioxidants in pharmaceutical packaging plastic pellets in the market used by pharmaceutical packaging manufacturers.Methods:Using acetonitrile as the extraction solvent,HPLC was adopted for determination of antioxidants content in plastic pellets.The chromatographic column was Diamonsil C18(150 mm×4.6 mm,5 μm).The mobile phase was acetonitrile and water with a gradient mode at the flow rate of 1.5,1.8 mL·mol-1.The UV detection wavelength was set at 224 nm.Results:This method could separate and determine eight kinds of commonly used antioxidants quickly and effectively.The antioxidants showed good linear relationship in a certain concentration ranges and the recoveries met the requirement.The 25 kinds of plastic pellets from different sources were collected for the determination of their antioxidant content,and the results were gathered to facilitate the selection of raw material for packaging in the future.The determination results of antioxidant 245,antioxidant 1178,antioxidant 264,antioxidant 1010,antioxidant 330,antioxidant 1076 and antioxidant 168 were 0.012%-0.046%,0-0.016%,0.002%-0.012%、0.003%-0.086%,0.007%-0.081%,0.006%-0.057%,respectively.Conclusion:The method is simple,accurate,and can be used for the determination of 8 commonly used antioxidants in pharmaceutical packaging plastic pellets and quality control.

关 键 词：药品包装材料 塑料粒料 抗氧剂 高效液相色谱 含量测定 

分 类 号：R917[医药卫生—药物分析学]