HPLC-ELSD法同时测定芪蛭通络胶囊中2个皂苷类成分的含量  

Determination of two saponins in Qizhi Tongluo capsules by HPLC-ELSD

作　　者：李婷[1] 程显隆[2] 王郡瑶 李明华[2] 李涛 游蓉丽 魏锋[2] 李向日[1] 马双成[2] LI Ting;CHENG Xian-long;WANG Jun-yao;LI Ming-hua;LI Tao;YOU Rong-li;WEI Feng;LI Xiang-ri;MA Shuang-cheng(Centre of TCM Processing Research,Beijing University of Chinese Medicine,Beijing Key Laboratory for Quality Evaluation of Chinese Materia Medica,Beijing 102488,China;National Institutes for Food and Drug Control,Beijing 100050,China;Shanxi Zhendong Pharmaceutical Co.,Ltd.,Changzhi 047100,China;Beijing Zhendong Guangming Pharmaceutical Research Institute Co.,Ltd.,Beijing 100085,China)

机构地区：[1]北京中医药大学中药炮制研究中心/北京市中药品质评价重点实验室,北京102488 [2]中国食品药品检定研究院,北京100050 [3]山西振东制药股份有限公司,长治047100 [4]北京振东光明药物研究院有限公司,北京100085

出　　处：《药物分析杂志》2022年第4期720-726,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC-ELSD同时测定芪蛭通络胶囊中人参皂苷Rb;和黄芪甲苷2个成分含量的方法,提高、完善芪蛭通络胶囊的质量标准。方法:采用Waters SunFire-C_(18)色谱柱(150 mm×4.6 mm,5μm),以乙腈-水为流动相,梯度洗脱,流速1 mL·min^(-1),柱温25℃,All Chrom ELSD 6000蒸发光散射检测器(漂移管温度105℃,氮气流量3 L·min^(-1))。结果:人参皂苷Rb;和黄芪甲苷的线性范围分别为0.48~15.96、0.51~17.05μg,相关系数分别为0.9993和0.9999;加样回收率(n=6)分别为100.3%、104.2%,平均含量分别为1.23、1.08 mg·g^(-1)。结论:本方法简便、灵敏、准确,可用于芪蛭通络胶囊中人参皂苷Rb_(1)和黄芪甲苷2个成分的含量测定。Objective:To develop an HPLC-ELSD method for simultaneous determination of ginsenoside Rb_(1)and astragalosideⅣin Qizhi Tongluo capsules.To improve the quality standard of Qizhi Tongluo capsules.Methods:HPLC analysis was performed on an Waters SunFire-C_(18)column(150 mm×4.6 mm,5μm)with gradient elution of acetonitrile and water,and the flow rate was set at 1.0 mL·min^(1),and the column temperature was 25℃.The flow rate of N_(2)in ELSD was set at 3 L·min^(1),and the temperature of drift tube was set at 105℃.Results:The results were obtained that quantitative linear ranges of two components were 0.48-15.96μg and 0.51-17.05μg respectively,the correlation coefficientswere 0.9993 and 0.9999 respectively,the average recoveries(n=6)were 100.3%and 104.2%respectively,and theaveragecontents were 1.23 mg·g^(-1)and 1.08 mg·g^(-1)respectively.Conclusion:A specific,sensitive,simple and reproducible HPLC-ELSD method has been established for the determination of ginsenoside Rb_(1)and astragalosideⅣin Qizhi Tongluo capsules.

关 键 词：芪蛭通络胶囊 高效液相色谱-蒸发光散射检测 人参皂苷 黄芪甲苷 含量测定 质量控制 

分 类 号：R917[医药卫生—药物分析学]