输液袋用聚碳酸酯组合盖中双酚A含量及双酚A向输液中迁移量的测定

Determination of Bisphenol A in Infusion Used Combined Cover and Bisphenol A Migration into Infusion by HPLC

目的建立输液袋用聚碳酸酯组合盖中双酚A含量及双酚A向输液中迁移量的高效液相色谱测定法。方法采用Diamosil-C18（4．6mm×250mm，5μm）色谱柱；流动相为甲醇-水（80：20），检测波长为227nm，流速1．0mL·min＾-1。结果双酚A在1．354-27．08ng内呈良好的线性关系（r=0．9999）；聚碳酸酯组合盖中双酚A含量和双酚A向输液中迁移量测定的平均回收率分别为91．7％（RSD=2．3％）和93．9％（RSD=1．8％）。结论该方法准确、灵敏、简便，适用于对输液袋用聚碳酸酯组合盖中双酚A含量及双酚A向输液中迁移量的测定。

OBJECTIVE To develop a method for determination of bisphenol A in Infusion Used Combined Cover and bisphenol A migration into infusion by HPLC. METHODS A Diamosil-C18 column（4.6 mm×250 mm, 5μm） and a DAD detector was adopted with methanol and water（80 ： 20） as mobile phase. The wavelength was 227 nm, the flow rate was 1.0 mL.min-1. RESULTS The method had a linear range in 1.354-27.08 ng （r=0.999 9）. The average recovery of bisphenol A and bisphenol A migration was 91.7%（RSD=2.3%） and 93.9%（RSD=l.8%）, respectively. CONCLUSION This method is accurate, sensitive, simple, and can be used for determination of bisphenol A and bisphenol A migration into infusion from Infusion Used Combined Cover.