摘要
目的 建立鹿瓜多肽注射液、注射用鹿瓜多肽中半乳糖、葡萄糖、甘露糖、蔗糖和果糖的离子色谱测定方法.方法 使用Dionex CarboPac PA20 色谱柱(150 mm×3 mm,6 μm);Dionex PA20 Guard预柱(30 mm×3 mm,6 μm);流动相:水-250 mmol/L氢氧化钠溶液-1 mol/L醋酸钠溶液,梯度洗脱;体积流量:0.4 mL/min;柱温:30℃;进样量:25 μL;检测器:电化学检测器.结果 半乳糖、葡萄糖、甘露糖、蔗糖、果糖的线性范围均为 0.1～10.0 μg/mL(r＞0.995 0),平均回收率分别为 96.52%、97.80%、97.03%、97.72%、98.35%,RSD值分别为 2.88%、1.49%、2.01%、1.83%、1.84%.结论 该方法快速准确、重现性好,可用于鹿瓜多肽注射剂中糖类杂质的测定.
Abstract
Objective To establish a ion chromatography method for determination of galactose,glucose,mannose,sucrose,and fructose in Cervus and Cucumis Polypeptide Injection and Cervus and Cucumis Polypeptide for injection.Methods Dionex CarboPac PA20 column(150 mm×3 mm,6 μm)and Dionex PA20 Guard column(30 mm×3 mm,6 μm)was used.Mobile phase was water-250 mmol/L sodium hydroxide solution-1 mol/L sodium acetate solution with gradient elution.Volume flow rate was 0.4 mL/min,column temperature was set at 30℃,and injection volume was 25 μL.Electrochemical detector was adopted.Results The linear ranges of galactose,glucose,mannose,sucrose,and fructose were 0.1—10.0 μg/mL(r>0.995 0),and their average recoveries were 96.52%,97.80%,97.03%,97.72%,and 98.35% with RSD 2.88%,1.49%,2.01%,1.83%,and 1.84% .Conclusion The method is fast,accurate,and has good reproducibility,and can be used for the determination of carbohydrate impurities in Cervus and Cucumis Polypeptide Injection.
基金项目
天津市市场监督管理委员会科技计划项目(2020-W26)
天津市药品监督管理局科技计划项目(2020-YJ02)
NETL
NSTL
万方数据