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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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HPLC-DAD双波长法测定护肝片中5个柴胡皂苷的含量

Simultaneous determination of five saikosaponins in Hugan tablets by HPLC-DAD dual wavelength method

作者(英文):
分类号:R917
出版年·卷·期(页码):2019,39 (12):2248-2253
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立测定护肝片中柴胡皂苷a、柴胡皂苷b1、柴胡皂苷b2、柴胡皂苷c、柴胡皂苷d的定量分析方法。方法:采用Agilent Eclipse Plus C18(250 mm×4.6 mm,5 μm)色谱柱,流动相为乙腈(A)-水(B),梯度洗脱(0~40 min,30% A→53% A;40~48 min,53% A→98% A),检测波长210 nm(柴胡皂苷a、柴胡皂苷c、柴胡皂苷d)、254 nm(柴胡皂苷b1、b2),流速1 mL·min-1,柱温25℃。结果:5个柴胡皂苷分离度良好;柴胡皂苷a、柴胡皂苷b1、柴胡皂苷b2、柴胡皂苷c、柴胡皂苷d进样量分别在0.013 5~0.674、0.015 6~0.781、0.015 2~0.762、0.015 1~0.757和0.013 1~0.653 μg范围内线性关系良好(r≥0.999 5);稳定性及重复性试验RSD均低于2.0%;平均回收率在99.7%~102.9%,RSD均小于2.0%(n=6)。12个生产厂家50批样品中均未检测到柴胡皂苷a、柴胡皂苷c、柴胡皂苷d,除2个厂家外的其余厂家样品中均检测到柴胡皂苷b1、柴胡皂苷b2结论:所建立的方法简便、快捷、重复性好,可用于护肝片中5个柴胡皂苷的含量测定,为护肝片的全面质量控制提供科学依据。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish a quantitative method for determination of saikosaponin a,saikosaponin b1,saikosaponin b2,saikosaponin c and saikosaponin d in Hugan tablets. Methods: HPLC experiment was performed on an Agilent Eclipse Plus C18 column (250 mm×4.6 mm,5.0 μm). The mobile phase consisted of acetonitrile (A) -water (B) in gradient mode (0-40 min,30%A→53%A;40-48 min,53%A→98%A). The detection wavelength was set at 210 nm for saikosaponin a,saikosaponin c,saikosaponin d and 254 nm for saikosaponin b1,saikosaponin b2. The flow rate was 1 mL·min-1. The column temperature was maintained at 25℃. Results: The results showed that the separation of the five saikosaponins was good. Saikosaponin a,saikosaponin b1,saikosaponin b2,saikosaponinc and saikosaponin d showed good linear relationship within the range of 0.0135-0.674,0.0156-0.781,0.0152-0.762,0.0151-0.757 and 0.0131-0.653 μg,respectively (r ≥ 0.9995). Good precision,stability and reproducibility was achieved with the RSDs below 2.0%. The average recoveries of saikosaponin a,saikosaponin b1,saikosaponin b2,saikosaponinc and saikosaponin d were among 99.7%-102.9% with RSDs below 2.0%. Saikosaponin a,saikosaponin c and saikosaponin d was not detected in fifty batches of samples from twelve companies. Saikosaponin b1 and saikosaponin b2 were detected in most samples except samples from two companies. Conclusion: The method is simple,rapid and reproducible. It can be used for the determination of the five saikosaponins in Hugan Tables,providing a scientific basis for the comprehensive quality control of Hugan Tables.

-----参考文献:---------------------------------------------------------------------------------------

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