一测多评法测定复方白芷止痛胶囊中4种指标成分

Content Determination of Four Index Components in Compound Baizhi Zhitong Capsules by QAMS Method

目的以欧前胡素为内标物,建立测定复方白芷止痛胶囊中阿魏酸、绿原酸、异欧前胡素多种指标性成分含量的一测多评方法。方法采用HPLC,色谱柱为Thermo Hypersil GOLD(4.6 mm×250 mm,5μm),以乙腈-0.2%甲酸为流动相,梯度洗脱,柱温30℃,检测波长分别为320 nm(绿原酸、阿魏酸)和300 nm(欧前胡素、异欧前胡素),流速为1 mL/min进行测定。以欧前胡素为内标物,建立复方白芷止痛胶囊中阿魏酸、绿原酸、异欧前胡素的相对校正因子。结果复方白芷止痛胶囊中阿魏酸、绿原酸、异欧前胡素的相对校正因子重现性良好,分别为1.16、2.00、1.00,一测多评法测定结果与外标法比较无显著差异。结论以欧前胡素为内标物建立复方白芷止痛胶囊多种指标性成分的一测多评法结果准确性良好,方法可行,可作为复方白芷止痛胶囊的质量控制方法。

Objective To develop a new method for content determination of chlorogenic acid, ferulic acid, and isoimperatorin in Compound Baizhi Zhitong Capsules through quantitative analysis of multi-components by single-marker（QAMS） method by setting imperatorin as internal standard substance. Methods HPLC was adopted. The chromatographic column of Thermo Hypersil GOLD（4.6 mm×250 mm, 5 μm） was used; the mobile phase was composed of acetonitrile and 0.2% formic acid in gradient elution; the flow speed was 1 m L/min; the detection wavelength were 320 nm（chlorogenic acid, ferulic acid） and 300 nm（imperatorin and isoimperatorin）. The relative analysis correction factors of imperatorin to other three components were established by setting imperatorin as internal standard substance. Results The relative analysis correction factors of chlorogenic acid, ferulic acid, and isoimperatorin in Compound Baizhi Zhitong Capsules were 1.16, 2.00, and 1.00, which had a high reproducibility. There was no significant difference between QAMS and external standard method. Conclusion The QAMS method for Compound Baizhi Zhitong Capsules by setting imperatorin as internal standard substance is accurate and feasible, which can be used as a useful quality control method for Compound Baizhi Zhitong Capsules.