离子色谱法测定鹿瓜多肽注射剂中半乳糖、葡萄糖、甘露糖、蔗糖和果糖  

Determination of galactose,glucose,mannose,sucrose,and fructose in Cervus and Cucumis Polypeptide Injection by ion chromatography

作　　者：张晶 苏喆 覃婷婷 韩晓捷 ZHANG Jing;SU Zhe;QIN Tingting;HAN Xiaojie(Tianjin Institute for Drug Control,Tianjin 300070,China)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《现代药物与临床》2024年第7期1747-1751,共5页Drugs & Clinic

基　　金：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)。

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,6μm);Dionex PA20 Guard预柱(30 mm×3 mm,6μm);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:25μL;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0.1~10.0μg/mL(r>0.9950),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。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,6μm)and Dionex PA20 Guard column(30 mm×3 mm,6μm)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 25μL.Electrochemical detector was adopted.Results The linear ranges of galactose,glucose,mannose,sucrose,and fructose were 0.1—10.0μg/mL(r>0.9950),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.

关 键 词：鹿瓜多肽注射液 注射用鹿瓜多肽 半乳糖 葡萄糖 甘露糖 蔗糖 果糖 离子色谱法 

分 类 号：R927.1[医药卫生—药学]