HPLC双标多测法测定银黄口服液中7个成分的含量  

Determination of Seven Components in Yinhuang Oral Liquid by HPLC TRSDMC

作　　者：栾永福 周广涛 许丽丽 马双成[3] 孙磊[3] 林永强 郭东晓 LUAN Yong-fu;ZHOU Guang-tao;XU Li-li;MA Shuang-cheng;SUN Lei;LIN Yong-qiang;GUO Dong-xiao(NMPA Key Laboratory for Quality Evaluation of Gelatin Products,Shandong Engineering Laboratory for StandardInnovation and Quality Evaluation of TCM,Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong University of TCM,Jinan 250355,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]山东省食品药品检验研究院国家药监局胶类产品质量评价重点实验室山东省中药标准创新与质量评价工程实验室,山东济南250101 [2]山东中医药大学,山东济南250355 [3]中国食品药品检定研究院,北京100050

出　　处：《食品与药品》2022年第4期304-309,共6页Food and Drug

基　　金：山东省重点研发计划(软科学项目)(编号:2020RKB24001)。

摘　　要：目的建立高效液相色谱(HPLC)双标多测法,测定银黄口服液中7个成分(新绿原酸、绿原酸、隐绿原酸、3,4-O-二咖啡酰奎宁酸、3,5-O-二咖啡酰奎宁酸、4,5-O-二咖啡酰奎宁酸、黄芩苷)的含量。方法采用HPLC,借助DRS Origin软件,以绿原酸(峰2)和黄芩苷(峰7)为双标化合物,采用双标线性校正法进行色谱峰定性;以双标化合物中的绿原酸为参照物,用相对校正因子法对其他6种成分进行定量。同时,分别采用相对校正因子法和外标法对20批不同企业生产的银黄口服液样品中上述7个成分进行含量测定。结果使用DRS Origin软件可准确定性色谱峰。新绿原酸、隐绿原酸、3,4-O-二咖啡酰奎宁酸、3,5-O-二咖啡酰奎宁酸、4,5-O-二咖啡酰奎宁酸和黄芩苷对绿原酸的相对校正因子分别为0.9606,09612,1.0243,1.2603,1.2394,1.0872,使用该相对校正因子计算的含量和外标法结果的绝对偏差均小于0.1 mg/ml,且建立的方法符合方法学验证要求,平均回收率分别为98.62%,102.58%,100.41%,104.76%,103.17%,102.95%,97.39%(n=6),RSD分别为1.93%,1.08%,1.10%,0.74%,0.92%,0.78%,1.13%。结论双标多测法作为一种新的替代对照品方法,可用于银黄口服液中7个成分的质量评价,方法可行、准确且经济实用,值得应用和推广。Objective To establish a method using two reference substances for determination of multiple components(TRSDMC)for simultaneous determination of seven components(neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,3,4-O-dicaffeoyl quinic acid,3,5-O-dicaffeoyl quinic acid,4,5-O-dicaffeoyl quinic acid and baicalin)in Yinhuang Oral Liquid.Methods HPLC was adopted.The chromatographic peaks were identified by linear calibration using both chlorogenic acid(peak 2)and baicalin(peak 7)as reference substances with the aid of DRS origin software.Quantitative analysis of six other components was carried out by relative correction factor method(RCFM)with chlorogenic acid as reference substance.At the same time,RCFM and external standard method(ESM)were used to determine the contents of the above seven components in 20 batches of Yinhuang Oral Liquid samples produced by different enterprises.Results The chromatographic peaks could be accurately identified with the aid of DRS origin software.The relative correct factors of neochlorogenic acid,cryptochlorogenic acid,3,4-O-dicaffeoyl quinic acid,3,5-O-dicaffeoyl quinic acid,4,5-O-dicaffeoyl quinic acid,baicalin vs chlorogenic acid were 0.9606,09612,1.0243,1.2603,1.2394,1.0872,respectively.The absolute deviation of the contents of seven components in 20 batches of Yinhuang Oral Liquid samples from different manufacturing enterprises determined by RCFM and ESM were not more than 0.1 mg/ml,and the established method met the requirements of methodological validation.The average recoveries were 98.62%,102.58%,100.41%,104.76%,103.17%,102.95%and 97.39%(n=6),respectively,with RSDs of 1.93%,1.08%,1.10%,0.74%,0.92%,0.78%and 1.13%.Conclusion As a new alternative reference method,TRSDMC is feasible,reliable and economical for quality evaluation of Yinhuang Oral Liquid,thus is worthy of application and promotion.

关 键 词：银黄口服液 DRS Origin软件 双标多测法 相对校正因子法 外标法 

分 类 号：R917[医药卫生—药物分析学]