一测多评法同时测定妇科调经片中7个成分的含量

目的： 建立一测多评法同时测定妇科调经片中芍药内酯苷、芍药苷、阿魏酸、洋川芎内酯Ⅰ、去氢紫菫碱、洋川芎内酯A和藁本内酯7个成分的含量。方法： 采用Phenomenex Luna C₁₈色谱柱（4.6 mm×250 mm，5 μm），以乙腈-0.1%磷酸水溶液为流动相，梯度洗脱，流速1.0 mL·min^-1，柱温30℃，检测波长为230 nm（0~25 min，检测芍药内酯苷、芍药苷）、322 nm（25~40 min，检测阿魏酸）、280 nm（40~50 min，60~80 min，检测洋川芎内酯Ⅰ、洋川芎内酯A、藁本内酯）、335 nm（50~60 min，检测去氢紫堇碱）。以阿魏酸为内参物，建立其与芍药苷、洋川芎内酯Ⅰ、去氢紫菫碱、洋川芎内酯A和藁本内酯的相对校正因子；同时采用一测多评法和外标法测定妇科调经片中7个成分的含量，并将2种方法的测定结果进行比较。结果： 在一定线性范围内，阿魏酸与芍药内酯苷、芍药苷、洋川芎内酯Ⅰ、去氢紫菫碱、洋川芎内酯A和藁本内酯的相对校正因子分别为5.6、3.2、1.0、3.3、2.7、2.4，且在不同实验条件下重现性良好；一测多评法与外标法测定结果无明显差异。结论： 同时建立了妇科调经片中7个成分的一测多评法，经方法学验证，该法可用于妇科调经片的质量控制。

Objective: To establish a quantitative analysis of multi-components by single marker(QAMS)method for simultaneous determination of seven components(albiflorin,paeoniflorin,ferulic acid,senkyunolideⅠ, dehydrocorydaline,senkyunolide A and ligustilide)in Fuke Tiaojing tablets.Method: Phenomenex Luna C₁₈ column(4.6 mm×250 mm,5 μm)was chosen,the mobile phase consisted of acetonitrile-0.1% phosphoric acid water with gradient elution at a flow of 1.0 mL·min^-1,and the column temperature was 30℃.The detection wavelengths were set at 230 nm(0-25 min for albiflorin and paeoniflorin),322 nm(25-40 min for ferulic acid),280 nm(40-50 min,60-80 min for senkyunolide Ⅰ senkyunolide A and ligustilide)and 335 nm(50-60 min for dehydrocorydaline).Ferulic acid was used as the internal reference standard,and 6 relative correction factors(RCFs)to ferulic acid were calculated.The contents of seven components in Fuke Tiaojing Tablets were determined by both QAMS and external standard method.Results: The RCFs of albiflorin,paeoniflorin,senkyunolide Ⅰ,dehydrocorydaline,senkyunolide A and ligustilide with reference to ferulic acid were 5.6,3.2,1.0,3.3,2.7 and 2.4,respectively and the reproducibility was good under different experimental conditions.There was no significant difference observed between the quantitative results of the two methods.Conclusions: The method of QAMS for seven components in Fuke Tiaojing tablets was established.The methodology validation showed that the method can be used for quality control of Fuke Tiaojing tablets.

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