摘要
目的:建立HPLC同时测定固本益肠片中儿茶素、表儿茶素、芍药苷、补骨脂素及异补骨脂素含量的方法并为监测该药风险成分提供参考。方法:色谱柱采用依利特Hypersil ODS2柱(4.6 mm×300 mm,5μm);流动相:乙腈(B)-水(A),梯度洗脱,检测波长:240 nm;流速:1.0 mL·min^(-1);柱温:30℃。结果:5种成分均能达到基线分离,且在相应范围内线性关系良好;儿茶素、表儿茶素、芍药苷、补骨脂素及异补骨脂素的平均加样回收率分别为98.22%、96.93%、101.46%、98.60%和100.24%,RSD分别为1.5%、2.1%、2.0%、1.4%和1.0%(n=6)。结论:经方法学验证,本法可为进一步完善固本益肠片质量控制标准,并为监测该药风险成分提供参考。
Objective:To establish a method for HPLC to simultaneously determine the contents of catechins,epicatechins,peony glycosides,psoralens and isopsoralens in Guben Yichang tablets,and it was established to provide a reference for monitoring the risk components of the drug.Methods:The column was Hypersil ODS2 column(4.6 mm×300 mm,5μm).Mobile phase:acetonitrile(B)-water(A),gradient elute,detection wavelength:240 nm;Flow rate:1.0 mL·min^(-1).Column temperature:30℃.Results:All five components could achieve baseline separation and had good linear relationships within the corresponding range.The average dosing recoveries of catechins,epicatechins,peony glycosides,psoralens and isopsoralens were 98.22%,96.93%,101.46%,98.60%and 100.24%,and RSD were 1.5%,2.1%,2.0%,1.4%and 1.0%,respectively(n=6).Conclusion:After methodological verification,this method can further improve the quality control standards of Guben Yichang intestinal tablets and provide a reference for monitoring the risk ingredients of the drug.
作者
钱洲
王月德
许庆
安艳苏
毕秋左
张顺平
QIAN Zhou;WANG Yuede;XU Qing;AN Yansu;BI Qiuzuo;ZHANG Shunping(Qujing City Food and Drug Testing Center,Qujing,Yunnan 655000,China)
出处
《中国药品标准》
CAS
2023年第4期438-443,共6页
Drug Standards of China
