HPLC-RID法测定复方右旋糖酐70滴眼液中右旋糖酐70的含量

摘要

目的:建立测定复方右旋糖酐70滴眼液中右旋糖酐70含量的方法.方法:采用高效液相色谱-示差折光检测法.色谱柱为Phenomenex PolySep-GFC-P 4000,流动相为0.7%Na2SO4溶液,流速为0.5 ml/min,柱温为35℃,进样量为50μl,示差折光检测器检测池温度为40℃.结果:右旋糖酐70检测质量浓度线性范围为0.1~5.0 mg/ml(r=0.999 5);精密度、稳定性、重复性试验的RSD<2%;平均回收率为97.45%~101.76%,RSD为0.57%(n=9).结论:本方法简便、快速、可靠,分离度高,分析时间短,可用于复方右旋糖酐70滴眼液中右旋糖酐70的含量测定.%OBJECTIVE:To establish a method for determination of dextran70 in Compound dextran70 eye drop. METHODS:HPLC-RID was performed on the column of Phenomenex PolySep-GFC-P 4000 with the mobile phase of 0.7% Na2SO4 solution. The flow rate was 0.5 ml/min,column temperature was 35 ℃ and injection volume was 50 μl,and the inner temperature of refrac-tive index detector was 40 ℃. RESULTS:The linear range of dextran70 was 0.1-5.0 mg/ml(r=0.999 5);RSDs of precision,sta-bility and reproducibility tests were lower than 2%;average recovery was 97.45%-101.76%(RSD=0.57%,n=9). CONCLU-SIONS:The method is simple,fast and reliable with high separation and short analysis time,and can be used for the content deter-mination of dextran70 in Compound dextran70 eye drop.