5%葡萄糖注射液中外源性抗氧剂的测定

目的建立HPLC法测定聚丙烯瓶装5%葡萄糖注射液中抗氧剂1010和168的含量,研究抗氧剂向注射液迁移情况。方法采用伊利特C18柱（250 mm×4.6 mm,5μm）为色谱柱;乙腈-四氢呋喃-水（62∶30∶8）为流动相;流速：1.5 ml·min-1;检测波长：276 nm。结果抗氧剂1010在0.61～363.66 mg·L-1范围内线性关系良好,平均回收率为91.07%,RSD=1.48%;抗氧剂168在1.21～362.66 mg·L-1范围内线性关系良好,平均回收率为93.53%,RSD=1.07%。结论聚丙烯瓶材料中抗氧剂向5%葡萄糖注射液中进行了迁移,有定量控制的必要,本法快速、准确,可用于测定抗氧剂1010和168的含量。

Determination of antioxidant 1010 and antioxidant 168 contained in 5% glucose injection by HPLC

Aim To establish an HPLC method for determination of antioxidant 1010 and antioxidant 168 contained in 5% glucose injection.Methods The determination was carried out by using a Yilite C18 column(250 mm × 4.6 mm,5 μm) with acetonitrile tetrahydrofuran-water(62∶30∶8) as mobile phase.The UV detection wavelength was 276 nm and the flow rate was 1.5 ml.min-1.Results Under the chromatographic conditions used,there were no interferences found in the positions of antioxidant 1010 peak and antioxidant 168peak.Antioxidant 1010 and antioxidant 168 had good linear responses in the concentration ranges of 0.61 ～ 363.66 mg.L-1and 1.21～362.66 mg.L-1 respectively.The average recoveries of antioxidant 1010 and antioxidant 168 in 5% glucose injection were 91.07%with the relative standard deviation of 1.48% and 93.53% with the relative standard deviation of 1.07% respectively.Conclusion There are antioxidant 1010 and antioxidant 168 in the 5% glucose injection.It is necessary to control the quantity of antioxidant 1010 and antioxidant 168 in the 5% glucose injection.The method employed in this analysis is reliable and convenient with good repetition and can be used for quality control in the production of 5% glucose injection.