目的 建立高效液相色谱法检查右旋糖酐40氯化钠注射液中5-羟甲基糠醛限量.方法 采用十八烷基硅烷键合硅胶柱(250 mm×4.6 mm,5 μm);以1 g·L-1磷酸溶液-甲醇(90:10)为流动相;流速为1.0 mL·min-1;检测波长为284 nm;柱温为35℃.结果 5-羟甲基糠醛在0.248 4～24.84 mg·L-1质量浓度范围内与峰面积呈良好的线性关系,线性方程为Y=152 947.8X-9 816.5,r=1.000,方法回收率为99.2%(n=6),RSD为0.7%.结论 该法简便准确,适用于右旋糖酐40氯化钠注射液中5-羟甲基糠醛限量测定.%Objective To establish an HPLC method for assay of 5-hydroxymelthy furfural in Dextran 40 and Sodium Chloride Injection. Methods The chromatographic conditions adopted were as follows:a C18 column (250 mm×4. 6 mm,5 μm) ,a mobile phase of 1 g ? L-1 phosphoric acid solution - methanol (90 : 10) ,and the flow rate at 1. 0 ml. ? Min~' ; the detection wavelength at 284 nm;the column temperature maintained at 35℃. Result The calibration curve was linear with in the concentration range of 0. 248 4-24. 84 mg ? L-1 ,with the regression equationY = 152 94 7. 8X-9 816. 5 (r =1. 000) ,and the average recovery was 99. 2%{ n =6). Conclusion The method is simple and accurate for the limit control of 5-hydroxymelthy furfural in Dextran 40 and Sodium Chloride Injection.
展开▼
