基于HPLC方法测定预灌封注射器组合件中丙烯酸浸出量  

Determination of Acrylic Acid Migration from Prefilled Syringe Assembly Based on HPLC

作　　者：周光耀 余黛媚 张怡 ZHOU Guang-yao;YU Dai-mei;ZHANG Yi(Guangzou Brunslab Co.,Ltd.,Guangdong Guangzhou 510000,China)

机构地区：[1]广州伯朗氏检测技术有限公司,广东广州510000

出　　处：《广州化工》2023年第18期62-64,共3页GuangZhou Chemical Industry

摘　　要：建立HPLC方法测定来源于预灌封注射器组合件中的丙烯酸的浸出量,应用该方法分析加速条件下不同时间点丙烯酸的含量。采用C18色谱柱(4.6 mm×150 mm, 5μm),流动相为0.1%磷酸-甲醇(80∶20),流速1.0 mL/min,检测波长220 nm,柱温35℃,进样量5μL。丙烯酸在0.43~17.20μg/mL浓度范围内线性关系良好(r=0.999 8),回收率为99.8%~101.0%,RSD为0.78%(n=6)。本研究建立的HPLC方法简便,准确,可靠,可适用于检测预灌封注射器组合件浸出物中丙烯酸的含量,为药品的质量安全提供技术参考。HPLC method for the determination of acrylic acid migration from prefilled syringe was established.At the same time,this method was used to analyze the migration of acrylic acid at different time points under accelerated conditions.The samples were separated on C 18 column(4.6 mm×150 mm,5μm)eluted with 0.1%phosphoric acid-methanol(80∶20)as mobile phase.The isocratic elution was used at a flow rate of 1.0 mL/min,the detection wavelength of 220 nm,the column temperature was 35℃.Acrylic acid was linear in the concentration range of 0.43~17.20μg/mL(r=0.9998).The average recoveries were all in a range of 99.8%~101.0%,RSD was 0.78%.The HPLC method established was simple,accurate and reliable.It could provide a technical reference for the quality control of drug and detection of PFS.

关 键 词：高效液相色谱 预灌封注射器 丙烯酸 浸出物 

分 类 号：R917[医药卫生—药物分析学]