HPLC-VWD-ELSD法同时测定黄甲软肝颗粒中6个成分的含量  

Simultaneous determination of six components in Huangjia Ruangan granules by HPLC-VWD-ELSD

作　　者：王宗权 黄朝情 黄志辉[4] 李艳英 高进 黄能听 刘军 张保献 滕利荣[4] WANG Zong-quan;HUANG Chao-qing;HUANG Zhi-hui;LI Yan-ying;GAO Jin;HUANG Neng-ting;LIU Jun;ZHANG Bao-xian;TENG Li-rong(Yingkerui(Zhuhai)Innovative Pharmaceutical Manufacturing Co.,Ltd,Zhuhai 519040,China;Beijing Yingkerui Pharmaceutical Research Institute Co.,Ltd,Beijing 102200,China;Yingkeru(i Hengqin)Pharmaceutical Research Institute Co.,Ltd,New Drug Delivery System Sub Center of National Research Center for Modern Engineering and Technology of Traditional Chinese Medicine,Engineering Technology Research Center of Guangdong Aerosol Inhalation Preparation,Zhuhai 519000,China;Zhuhai College of Jilin University,Zhuhai 519041,China)

机构地区：[1]盈科瑞(珠海)创新医药制造有限公司,珠海519040 [2]北京盈科瑞药物研究院有限公司,北京102200 [3]盈科瑞(横琴)药物研究院有限公司,国家中药现代化工程技术研究中心新型递药系统分中心,广东省雾化吸入制剂工程技术研究中心,珠海519000 [4]吉林大学珠海学院,珠海519041

出　　处：《药物分析杂志》2021年第7期1148-1154,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：广东省重点领域研发计划项目(2019B020201006);国家“重大新药创制”科技重大专项项目(2017ZX09301017);首届中国横琴科技创业大赛项目。

摘　　要：目的:采用高效液相色谱-紫外检测器-蒸发光散射检测器(HPLC-VWD-ELSD)法同时测定黄甲软肝颗粒中没食子酸、葛根素、芍药苷、三七皂苷R_(1)、黄芪甲苷和丹参酮Ⅱ_(A)的含量。方法:采用Waters Symmetry C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇(A)-0.1%醋酸水溶液(B),梯度洗脱,流速为1.0 m L·min^(-1)。没食子酸、葛根素和丹参酮Ⅱ_(A)采用VWD进行检测,检测波长为270 nm;芍药苷,三七皂苷R_(1)和黄芪甲苷采用ELSD进行检测,漂移管温度为70℃,载气流速2.0 L·min^(-1)。结果:没食子酸、葛根素、芍药苷、三七皂苷R_(1)、黄芪甲苷和丹参酮Ⅱ_(A)进样量分别在1.444-28.88、2.118-42.36、1.074-21.48、0.2180-4.360、0.1151-2.302和0.06670-1.334μg范围内与峰面积呈良好的线性关系;平均回收率(n=6)分别为93.8%、98.8%、97.5%、103.0%、100.6%和96.6%,RSD分别为1.4%、0.55%、3.3%、4.0%、3.9%和2.3%。5批黄甲软肝颗粒中上述6个成分的含量测定结果分别为2.612-3.203、9.155-10.342、7.044-9.863、0.622-0.841、1.529-1.697和0.719-0.957 mg·g^(-1)。结论:所建立的方法简便、快捷,重复性好,可用于黄甲软肝颗粒中6个成分的含量测定,为黄甲软肝颗粒全面的质量控制提供科学依据。Objective:To develop a method of high performance liquid chromatography-variable wavelength detector-evaporative light scattering detection(HPLC-VWD-ELSD)for simultaneous determination of gallic acid,puerarin,paeoniflorin,notoginsenoside R_(1),astragaloside and tanshinoneⅡ_(A) in Huangjia Ruangan granules.Methods:HPLC assay was performed on a Waters Symmetry-C_(18) column(250 mm×4.6 mm,5μm)with a mixture of methanol and 0.1%aqueous acetic acid as the mobile phase in gradient elution at the flow rate of 1.0 mL·min^(-1).Detection wavelength for gallic acid,puerarin and tanshinoneⅡ_(A) was set at 270 nm and ELSD was used for detection of paeoniflorin,notoginsenoside R_(1) and astragaloside.The temperature of the drift tube was maintained at 70℃and the nebulizing gas flow rate was 2.0 L·min^(-1).Results:The linear ranges of gallic acid,puerarin,paeoniflorin,notoginsenoside R_(1),astragaloside and tanshinoneⅡ_(A) were 1.444-28.88,2.118-42.36,1.074-21.48,0.2180-4.360,0.1151-2.302 and 0.06670-1.334μg,respectively.The average recoveries(n=6)were 93.8%with RSD of 1.4%,98.8%with RSD of 0.55%,97.5%with RSD of 3.3%,103.0%with RSD of 4.0%,100.6%with RSD of 3.9%,96.6%with RSD of 2.3%,respectively.The contents of the above-mentioned components in 5 samples were 2.612-3.203,9.155-10.342,7.044-9.863,0.622-0.841,1.529-1.697 and 0.719-0.957 mg·g^(-1),respectively.Conclusion:The method is simple,rapid and reproducible.It can be used for the determination of the six components in Huangjia Ruangan granules,providing a scientific basis for the comprehensive quality control of Huangjia Ruangan granules.

关 键 词：黄甲软肝颗粒 高效液相色谱-紫外检测器-蒸发光散射检测器 没食子酸 葛根素 芍药苷 三七皂苷R_(1) 黄芪甲苷 丹参酮Ⅱ_(A) 

分 类 号：R917[医药卫生—药物分析学]