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

摘要: 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(4.6 mm×250 mm，5 μm)色谱柱；流动相为甲醇-水(80∶20)，检测波长为227 nm，流速1.0 mL·min^-1。结果双酚A在1.354~27.08 ng内呈良好的线性关系(r=0.999 9)；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。

Abstract: 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, 5 μm) 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=1.8%), 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.