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、蔗糖和果糖的離子色譜測(cè)定方法。方法 使用Dionex CarboPac PA20色譜柱（150 mm×3 mm，6 μm）；Dionex PA20 Guard預(yù)柱（30 mm×3 mm，6 μm）；流動(dòng)相：水-250 mmol/L氫氧化鈉溶液-1 mol/L醋酸鈉溶液，梯度洗脫；體積流量：0.4 mL/min；柱溫：30 ℃；進(jìn)樣量：25 μL；檢測(cè)器：電化學(xué)檢測(cè)器。結(jié)果 半乳糖、葡萄糖、甘露糖、蔗糖、果糖的線性范圍均為0.1～10.0μg/mL（r＞0.995 0），平均回收率分別為96.52%、97.80%、97.03%、97.72%、98.35%，RSD值分別為2.88%、1.49%、2.01%、1.83%、1.84%。結(jié)論 該方法快速準(zhǔn)確、重現(xiàn)性好，可用于鹿瓜多肽注射劑中糖類雜質(zhì)的測(cè)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, 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.

R927.1

天津市市場(chǎng)監(jiān)督管理委員會(huì)科技計(jì)劃項(xiàng)目（2020-W26）；天津市藥品監(jiān)督管理局科技計(jì)劃項(xiàng)目（2020-YJ02）