HPLC法测定妇康丸中大黄素等6个成分的含量  

Simultaneous determination of six components including emodin in Fukang Pills by HPLC

作　　者：韩吴琦 吕晋 方慧祥 刘威峰 牛英颖 HAN Wuqi;L Jin;FANG Huixiang;LIU Weifeng;NIU Yingying(Kaifeng Institute for Food and Drug Control,Kaifeng 475000,China;Qujing Food and Drug Inspection and Testing Center,Qujing 655000,China)

机构地区：[1]开封市食品药品检验所,河南开封475000 [2]曲靖市食品药品检测中心,云南曲靖655000

出　　处：《中国药品标准》2022年第1期63-69,共7页Drug Standards of China

基　　金：河南省市场监督管理局科技计划项目(2020sj48)。

摘　　要：目的:建立同时测定妇康丸中橙皮苷、芦荟大黄素、大黄酸、大黄素、大黄酚和大黄素甲醚含量的HPLC方法。方法:采用依利特C_(18)(250 mm×4.6 mm,5μm)色谱柱;流动相为乙腈(A)-0.1%磷酸溶液(B),梯度洗脱;流速:1.0 mL·min^(-1);柱温:30℃;检测波长:283 nm,进样量:10μL。结果:在优化的色谱条件下,6个有效成分均具有良好的线性关系,前5个成分的线性范围分别为6.9486~69.4856μg·mL^(-1)、6.6704~66.7040μg·mL^(-1)、1.8247~18.2470μg·mL^(-1)、2.5092~25.0918μg·mL^(-1)、26.2416~262.4160μg·mL^(-1),其变异系数r均为1.0000,大黄素甲醚的线性范围为5.6470~56.4696μg·mL^(-1)(r=0.9999);平均回收率(n=6)分别为99.48%、98.96%、99.16%、99.28%、99.04%、98.82%,RSD分别为1.01%、0.36%、0.81%、0.85%、0.68%、0.85%。5批样品6个成分的平均含量分别为:14.1、9.3、5.5、7.6、22.5、12.8 mg/袋。结论:该方法快捷、操作简单、准确,具有良好的重复性和回收率,可为妇康丸的质量控制提供科学依据。Objective:To establish an HPLC method for simultaneous determination of hesperidin,aloe-emodin,rhein,emodin,chrysophanol and physcion in Fukang Pills.Methods:The test was performed in chromatographiccolumn Elite C_(18)(250 mm×4.6 mm,5μm)under the gradient elution of acetonitrile(mobile phase A)and 0.1%phosphoric acid(mobile phase B).The flow rate was 1.0 mL·min^(-1)and the column temperature was 30℃.Thedetection wavelength was set as 283 nm and the injection volume was 10μL.Results:The peak area andconcentration of six components had the good linearity under the optimized chromatographic condition.The linearityranges of hesperidin,aloe-emodin,rhein,emodin and chrysophanol fell into 6.9486-69.4856μg·mL^(-1),6.6704-66.7040μg·mL^(-1),1.8247-18.2470μg·mL^(-1),2.5092-25.0918μg·mL^(-1)and 26.2416-262.4160μg·mL^(-1)withr=1.0000 respectively.The linearity range of physcion fell into 5.6470-56.4696μg·mL^(-1)with r=0.9999.The average recoveries of six components were 99.48%,98.96%,99.16%,99.28%,99.04%and98.82%with RSDs as 1.01%,0.36%,0.81%,0.85%,0.68%and 0.85%(n=6)respectively.The averagecontents of six components in five batches of samples were 14.1,9.3,5.5,7.6,22.5 and 12.8 mg per bag re-spectively.Conclusion:The established method is quick,simple and accurate,and has the good repeatability andrecovery.It can provide the scientific basis for the quality control of Fukang Pills.

关 键 词：HPLC 妇康丸 有效成分 含量测定 

分 类 号：R921.2[医药卫生—药学]