【摘要】：目的:建立采用親水作用色譜(HILIC)測定阿卡波糖含量的新方法。方法:采用亞乙基橋雜化酰胺色譜柱(XBridge Amide,4.6 mm×250 mm,3.5μm),通過正交設(shè)計試驗考察了流動相pH、鹽濃度、柱溫及流速等色譜參數(shù)的影響,最終確立色譜條件:以10 mmol·L~(-1)乙酸銨緩沖鹽水溶液(pH 9.0)-乙腈(25∶75)為流動相,流速1.2 mL·min~(-1),柱溫65℃,檢測波長210 nm。結(jié)果:阿卡波糖與雜質(zhì)A可完全分離,且阿卡波糖質(zhì)量濃度在0.2~1.2 mg·mL~(-1)范圍內(nèi)線性關(guān)系良好(r=0.999 8);平均回收率為99.5%;供試品溶液在24 h內(nèi)穩(wěn)定;檢測限(S/N=3)為0.08μg;3批膠囊樣品中阿卡波糖含量分別為98.6%、100.0%、98.5%。結(jié)論:本法可用于阿卡波糖的質(zhì)量控制。
[Abstract]:Objective: to establish a new method for the determination of acarbose by hydrophilic interaction chromatography (HILIC). Methods: XBridge Amide,4.6 mm 脳 250 mm,3.5 渭 m), column was used to study the effects of the chromatographic parameters such as the concentration of pH, salt, the column temperature and the flow rate of the mobile phase by orthogonal design. The chromatographic conditions were as follows: 10 mmol L ~ (-1) ammonium acetate buffer salt solution (pH 9.0) -acetonitrile (25:75) as mobile phase, flow rate 1.2 mL min~ (-1), column temperature 65 鈩，

本文編號：2408898