中国药业2025，Vol.34Issue(8)：74-78,5.DOI:10.3969/j.issn.1006-4931.2025.08.017
高效液相色谱法同时测定桂附地黄丸(浓缩丸)中5种成分含量
Determination of Five Components in Guifu Dihuang Pills(Concentrated Pills)by High-Performance Liquid Chromatography
摘要
Abstract
Objective To establish a method for simultaneous determination of five components in Guifu Dihuang Pills(concentrated pills).Methods The sample content was determined by high-performance liquid chromatography(HPLC).The column was Welch Ultimate XB-C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 236 nm(morroniside,loganin,paeoniflorin)and 290 nm(cinnamaldehyde,paeonol),the injection volume was 10 μL,and the column temperature was 35 °C.The samples were analyzed by cluster analysis.Results Cinnamaldehyde,paeonol,paeoniflorin,morroniside,and loganin showed good linear relationships with peak areas within the ranges of 0.49-24.44 μg/mL(r=0.999 7),11.11-555.44 μg/mL(r=0.999 9),4.53-226.51 μg/mL(r=0.999 7),6.99-349.52 μg/mL(r=0.999 9),and 6.34-317.04 μg/mL(r=0.999 6)(n=6),respectively.The limits of quantification were 0.17,0.39,0.51,1.10,and 0.58 μg/mL,respectively.The RSDs of precision,stability,and repeatability tests were all less than 2%.The average recoveries were 96.69%,98.19%,99.37%,97.50%,and 98.09%,and the RSD were 1.53%,0.74%,1.99%,2.11%,and 1.75%(n=6),respectively.Cluster analysis classified the 21 batches of samples into six categories.Conclusion This method is simple,accurate,and can meet the requirements for simultaneous determination of the five components in Guifu Dihuang Pills(concentrated pills).关键词
桂附地黄丸(浓缩丸)/高效液相色谱法/聚类分析/含量测定Key words
Guifu Dihuang Pills(concentrated pills)/HPLC/cluster analysis/content determination分类
医药卫生引用本文复制引用
孙迎春,刘喜,刘东风,潘竹青..高效液相色谱法同时测定桂附地黄丸(浓缩丸)中5种成分含量[J].中国药业,2025,34(8):74-78,5.基金项目
安徽省药品监督管理局科技创新项目[AHYJ-KJ-202321]. （）
