HPLC法检测输液盖及注射液中双酚A的含量  

Determination of Bisphenol A(BPA) in Infusion Cover and Injection by HPLC

作　　者：杨锐[1] 孙会敏[1] 李樾[1] 史洋洋[2] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]北京石油化工学院

出　　处：《中国药事》2012年第7期689-692,共4页Chinese Pharmaceutical Affairs

基　　金：重大新药创制:国家科技重大新药创制"化学新药质量标准研究与评价技术平台"(编号2011ZX09303-001)

摘　　要：目的建立检测输液盖及注射液中双酚A含量的高效液相色谱法。方法采用二氯甲烷-甲醇萃取输液盖中双酚A单体,采用固相萃取柱(Cleanert PEP-SPE)富集注射液中迁移的双酚A,用HPLC法检测双酚A含量,色谱柱为ODS C18,柱温为室温,流动相为甲醇-水(3∶1),流速为0.8mL·min-1,检测波长为280nm。结果双酚A在0.20～80.00μg·mL-1范围内线性关系良好(r=0.9999),高、中、低3个浓度回收率均大于98%,RSD小于2%,3批输液盖中双酚A单体的含量分别为3.96、3.38、4.25μg·g-1。结论所建立的方法简便、准确、重复性好,可用于输液盖及注射液中双酚A的检测。Objective To develop an HPLC method for determination of Bisphenol A in infusion cover and injection.Methods Methylene dichloride-methanol was used as extraction solution to extract BPA from infusion cover,and the Cleanert PEP-SPE solid phase extraction column was used to concentrate the BPA in injection.The ODS C18 column was adopted with a mobile phase of methanol-water（3∶1）;the flow rate was 0.8 mL·min-1 with column temperature at room temperature;the wavelength of detection was set at 280 nm.Results A linearity relationship was obtained when the BPA concentration ranged from 0.20 to 80.00 μg· mL-1（r=0.9999）.The average recoveries of high,middle and low concentrations were all above 98%;the RSDs were all below 2%.The amount of BPA in 3 batches of infusion cover samples were 3.96,3.38,and 4.25 μg·g-1,respectively.Conclusion The established method is simple,reliable and reproducible,which can be used for the BPA detection in infusion cover and injection.

关 键 词：双酚A 输液盖 注射液 高效液相色谱法 迁移量 药包材与药物相容性 

分 类 号：R927.12[医药卫生—药学]