摘要
目的:建立七叶神安滴丸的超高效液相色谱(UPLC)指纹图谱鉴别方法,同色谱条件下完成一测多评法同时测定8个指标成分的含量.方法:采用Waters CORTECS ® T3(150 mm×2.1 mm,1.6 μm)色谱柱,以乙腈-0.1％磷酸水为流动相进行梯度洗脱,流速0.40 mL·min-1,柱温35 ℃,检测波长203 nm.结果:建立七叶神安滴丸UPLC指纹图谱,确立了 15个共有峰,15批样品相似度均大于0.99.并对其含量较高的8个成分人参皂苷Rb1、人参皂苷Rc、三七皂苷Fc、人参皂苷Rb2、人参皂苷Rb3、人参皂苷Rd、三七皂苷Fe和三七皂苷Fd采用一测多评的方法进行含量测定,15批次样品每丸8个成分含量之和在7.6～10.0 mg.8个成分在相应浓度范围内与峰面积的线性关系良好,平均加样回收率分别为99.8％、99.7％、99.1％、99.4％、101.8％、102.0％、99.2％和 100.2％,RSD 分别为 2.3％、2.2％、2.0％、1.5％、1.7％、1.2％、2.4％和2.6％.结论:本研究建立的七叶神安滴丸的UPLC指纹图谱及一测多评的含量测定方法,操作简单,重复性好,稳定可靠,可为七叶神安滴丸的质量控制提供更加全面的依据.
Abstract
Objective:To establish the ultra high performance liquid chromatography(UPLC)fingerprint of Qiye Shen'an dropping pills,and to determine the contents of 8 index components by quantitative analysis of multi-components by single marker at the same time.Methods:Waters CORTECS ® T3(150 mm ×2.1 mm,1.6 μm)chromatography column was used for gradient elution with acetonitrile-0.1％phosphoric acid as mobile phase,flow rate was 0.40 mL·min-1,column temperature was 35 ℃,detection wavelength was 203 nm.Results:The UPLC fingerprint of Qiye Shen'an dropping pills was established,8 common peaks were estab-lished,and the similarity of 15 batches of samples was greater than 0.99.Ginsenoside Rb1,ginsenoside RC,panax notoginseng saponin FC,ginsenoside Rb2,ginsenoside Rb3,ginsenoside Rd,panax notoginseng saponin Fe and panax notoginseng saponin Fd were determined by quantitative analysis of multi-components by single marker method.The contents of 8 components in 15 batches were between 7.6-10.0 mg per pill.The average recoveries were 99.8％,100.6％,99.8％,101.2％,102.1％,101.9％,99.7％and 100.2％respectively,and the RSDs were 2.3％,2.2％,2.0％,1.5％,1.7％,1.2％,2.4％and 2.6％respectively.Conclusion:The UPLC fingerprint of Qiye Shen'an dropping pills and the content determination method of quantitative analysis of multi-components by single marker method established in this study are simple to operation,and have good repeatability,stability and reliability,and can provide a more comprehensive basis for the quality control of Qiye Shen'an dropping pills.
基金项目
国家药典委员会标准制修订研究课题(2020Z006)
NETL
NSTL
万方数据