HPLC法测定健儿清解液中绿原酸等4种成分的含量  

Simultaneous determination of four components in Jianer qingjie oral liquid by HPLC

作　　者：毛菊华 余华丽 余乐 吴查青 范蕾 王伟影 MAO Juhua;YU Huali;YU Le;WU Chaqing;FAN Lei;WANG Weiying(Lishui Institute for Quality Inspection and Testing,Lishui 323000,China)

机构地区：[1]丽水市质量检验检测研究院,丽水323000

出　　处：《中国药品标准》2020年第6期515-520,共6页Drug Standards of China

基　　金：浙江省药品监督管理与产业发展研究会项目(编号:ZYH2020007);浙江省公共科技条件平台项目(2012E60008)。

摘　　要：目的:建立HPLC法同时测定健儿清解液中绿原酸、橙皮苷、川陈皮素和桔皮素4种成分的含量。方法:色谱柱为Agilent Zorbax SB-C 18色谱柱(4.6 mm×250 mm,5μm);流动相为乙腈-0.2%磷酸溶液,梯度洗脱,流速为1.0 mL·min^-1;柱温为30℃;DAD检测器,波长为284 nm(橙皮苷)和326 nm(绿原酸、川陈皮素、桔皮素)。结果:绿原酸、橙皮苷、川陈皮素、桔皮素分别在0.43~42.50μg·mL^-1(r=0.9999)、1.16~115.70μg·mL^-1(r=0.9996)、0.37~37.26μg·mL^-1(r=0.9999)、0.18~17.98μg·mL^-1(r=0.9999)之间呈良好的线性关系,平均加样回收率分别为:98.05%、98.97%、97.62%、97.87%,RSD%分别为1.64%、1.47%、1.23%、1.61%。测定样品50批,结果绿原酸、橙皮苷、川陈皮素、桔皮素的含量分别为低于定量限~5.65μg·mL^-1、0.17~9.42μg·mL^-1、低于定量限~7.13μg·mL^-1、低于定量限~3.47μg·mL^-1。结论:各批次健儿清解液样品中上述4种成分的含量差异均较显著,故亟需提升相应标准。本文建立的HPLC法专属性强、重现性好,可为有效控制健儿清解液质量提供参考依据。Objective:To establish a HPLC method for simultaneous determination the content of four components(chlorogenic acid,hesperidin,nobiletin and hesperetin)in Jianer Qingjie oral liquid.Methods:The method was performed on Agilent Zorbax SB-C 18 column(4.6 mm×250 mm,5μm)with column temperature of 30℃under the gradient elution of acetonitrile-0.2%phosphoric acid solution,and the flow rate was 1.0 mL·min^-1,the detection wavelength was 284 nm(hesperidin)and 326 nm(chlorogenic acid,nobiletin,hesperetin)respectively.Results:A good linearity of chlorogenic acid,hesperidin,nobiletin,hesperetin was at 0.43-42.50μg·mL^-1(r=0.9999),1.16-115.70μg·mL^-1(r=0.9996),0.37-37.26μg·mL^-1(r=0.9999),0.18-17.98μg·mL^-1(r=0.9999),respectively,and the average recovery rate were 98.05%with RSD 1.64%,98.97%with RSD 1.47%,97.62%with RSD 1.23%,97.87%with RSD 1.61%,respectively.The contents of chlorogenic acid,hesperidin,nobiletin,hesperetin in 50 batches of samples were less than LOQ-5.65μg·mL-1,0.17-9.42μg·mL^-1,less than LOQ-7.13μg·mL^-1,less than LOQ-3.47μg·mL^-1,respectively.Conclusion:The difference content of each target component content in 50 batches of Jianer Qingjie oral liquid was so significantly that it was necessary to establish an unified standard quality to control.The established method had high specificity and reproducibility,which can provide the basis for effectively control the quality of Jianer Qingjie oral liquid.

关 键 词：健儿清解液 HPLC 含量测定 绿原酸 橙皮苷 川陈皮素 桔皮素 

分 类 号：R921.2[医药卫生—药学]