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引用本文:肖小武,许妍,刘静佳,李丹,姜军华,罗跃华,洪挺.UHPLC-MS/MS同时测定参桂鹿茸丸中5种人参皂苷的含量[J].中国现代应用药学,2023,40(8):1104-1109.
XIAO Xiaowu,XUYan,LIU Jingjia,LI Dan,JIANG Junhua,Luo Yuehua,HONG Ting.Simultaneous determination of 5 ginsenosides in Shengui Lurong Pills by UHPLC-MS/MS[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(8):1104-1109.
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UHPLC-MS/MS同时测定参桂鹿茸丸中5种人参皂苷的含量
肖小武1, 许妍1, 刘静佳2, 李丹1, 姜军华1, 罗跃华1, 洪挺1
1.江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 国家药品监督管理局中成药质量评价重点实验室, 南昌 330029;2.南昌理工学院, 南昌 330044
摘要:
目的 建立同时测定参桂鹿茸丸中5种人参皂苷含量的UHPLC-MS/MS方法。方法 选用Agilent C18色谱柱(100 mm×2.1 mm,1.8 μm),柱温25 ℃,以甲醇-0.1%甲酸水梯度洗脱,流速为0.3 mL·min–1,ESI离子源,采用正离子多反应监测(MRM)监测模式。结果 人参皂苷Re、Rg1、Rf、Rb1以及拟人参皂苷F11浓度范围内线性良好,r2均>0.999 6,加样回收率为96.3%~104.9%,RSD(n=9)均<3.0%,仪器精密度、稳定性以及重复性的RSD均<3.0%。结论 该方法简单,准确,重复性好,可用于参桂鹿茸丸的质量控制和评价。
关键词:  参桂鹿茸丸  人参皂苷  超高液相色谱-串联质谱法
DOI:10.13748/j.cnki.issn1007-7693.20220741
分类号:R284.1
基金项目:
Simultaneous determination of 5 ginsenosides in Shengui Lurong Pills by UHPLC-MS/MS
XIAO Xiaowu1, XUYan1, LIU Jingjia2, LI Dan1, JIANG Junhua1, Luo Yuehua1, HONG Ting1
1.Jiangxi Institute For Drug Control, Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality, NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine, Nanchang 330029, China;2.Nanchang Institute of Technology, Nanchang 330044, China
Abstract:
OBJECTIVE To establish a UHPLC-MS/MS method for simultaneous determination of five ginsenosides in Shengui lurong pills. METHODS The determination was performed on Agilent C18(100 mm×2.1 mm, 1.8 μm) column with column temperature of 25 ℃. Methanol and 0.1% aqueous formic acid solution were used as mobile phase for gradient elution with the flow rate of 0.3 mL·min-1. Ion source was electrospray ion source, positive ion mode monitoring was conducted and MRM mode was adopted. RESULTS The linear ranges of ginsenoside Re, Rg1, Rf, Rb1 and pseudo-ginsenoside F11 had good resolution and linear relationships(r2≥0.999 6). The spiked recoveries were in the range of 96.3%-104.9% with RSD(n=9)<3.0%. RSDs of instrument precision, stability and reproducibility tests were <3.0%. CONCLUSION The method is simple, accurate, reliable, and can be uesd for quality control and evaluation of Shengui Lurong pills.
Key words:  Shengui Lurong pills  ginsenoside  UHPLC-MS/MS
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