UPLC-UV法测定注射用益气复脉(冻干)中人参皂苷Rg1、Re、Rb1  

UPLC-UV method for analysis of Ginsenoside Rg1,Re,and Rb1 in Yiqi Fumai Lyophilized Injection

作　　者：王伯昊 李洪英 李德坤[1,2] 林梅 胡靖 鞠爱春[1,2] WANG Bohao;LI Hongying;LI Dekun;LIN Mei;HU Jing;JU Aichun(Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections,Tianjin 300410,China)

机构地区：[1]天津天士力之骄药业有限公司,天津300410 [2]天津市中药注射剂安全性评价企业重点实验室,天津300410

出　　处：《药物评价研究》2020年第8期1587-1591,共5页Drug Evaluation Research

基　　金：天津市科技计划项目(18YFCZZC00430)。

摘　　要：目的建立UHPLC-UV测定注射用益气复脉(冻干)(YQFM)中人参皂苷Rg1、Re、Rb1含量的方法。方法采用Waters Xselect■HSS C18(3.0×150 mm,2.5μm)色谱柱,以0.05%磷酸溶液-乙腈为流动相梯度洗脱,进样量为5μL,检测波长为203 nm,柱温28℃。进行线性关系考察,重复性、中间精密度、准确性、耐用性试验。取10批YQFM,按照本研究建立的方法和YQFM国家药品标准(YBZ07062006-2009Z-2015)中的HPLC含量测定法[5]进行测定。结果人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1分别在0.01937~0.38740、0.02032~0.40640、0.05000~0.9999 mg/mL线性关系良好(R>0.9999),重复性、中间精密度、准确性、耐用性等均满足定量分析要求。含量测定结果与国家标准方法比较无明显差异。结论研究建立的方法可用于人参皂苷Rg1、Re、Rb1含量的测定,与传统的HPLC-UV法相比,本方法具有分析速度快、节约溶剂等特点,同时相较于UPLC-MS/MS法,具有经济、简便的优势。Objective To establish a UHPLC-UV method for the analysis of ginsenoside Rg1,Re,and Rb1 in Yiqi Fumai Lyophilized Injection.Methods The determination was achieved on a Waters Xselect?HSS C18 column(3.0 mm×150 mm,2.5μm)with a gradient elution system of 0.05%phosphoric acid solution-acetonitrile.The injection volume was 5μL with detection wavelength of203 nm,column temperature was maintained at 28℃.Linear relationship,repeatability,intermediate precision,accuracy and durability were tested.Ten batches of YQFM were selected and determined according to the method established in this study and the HPLC content determination method in YQFM national drug standard(YBZ07062006-2009 Z-2015).Results Ginsenoside Rg1,ginsenoside Re,Ginsenoside Rb1 the linear relationship was good in the range of 0.01937—0.38740,0.02032—0.40640,0.05000—0.99990 mg/mL respectively(r>0.9999).Repeatability,intermediate precision,accuracy and durability meet the requirements of quantitative analysis.There was no significant difference between the content determination results and the national standard method.Conclusion The method can be used for the determination of Ginsenoside Rg1,Re and Rb1.Compared with HPLC-UV method,this method has the characteristics of fast analysis speed and solvent saving.At the same time,it has the advantages of economy and simplicity compared with UPLC-MS/MS method.

关 键 词：UPLC 人参皂苷 注射用益气复脉(冻干) 方法学 

分 类 号：R285.6[医药卫生—中药学]