摘要
目的建立测定注射用转化糖含量的高效液相色谱(HPLC)法。方法采用Intersil氨基柱(250mm×4.6mm,5μm),以乙腈-水(85∶15)为流动相,示差折光检测器。结果葡萄糖和果糖质量浓度在0.8～8μg/mL范围内与峰面积线性关系良好,果糖和葡萄糖的平均回收率分别为99.19%和99.00%,RSD分别为0.60%和0.72%(n=9)。结论HPLC法灵敏度高、专属性强且便捷,可以很好地控制产品质量。
Objective To established a HPLC method for the determination of Invert Sugar for Injection. Methods The Intersil- NH2 column was used with the mobile phase of acetonitrile-water （85：15） and the detector was refractive index detector（RID）. Results The calibration curves of fructose and glucose were both linear in the concentration range of 0. 8 - 8 μg/mL. The average recovery rates of fructose and glucose were 99. 19% and 99.00%, RSD were 0. 60% and 0. 72% respectively. Conclusion The new method is sensitive, specific, rapid and simple. It can be used for the quality control of Invert Sugar for Injection.
出处
《中国药业》
CAS
2009年第21期29-30,共2页
China Pharmaceuticals
