小儿肺热咳喘颗粒中 3 种主要成分含量测定的HPLC 与 UHPLC 的方法转换

Method Conversion between HPLC and UHPLC for Determination of Three Main Components in Xiao'er Feire Kechuan Keli

  • 摘要: 为建立将小儿肺热咳喘颗粒中麻黄、黄芩苷和连翘苷 3 种主要成分含量测定的 HPLC 方法转换成 UHPLC 的方法。文章根据《中国药典》2020 版四部通则 0512 液相色谱法(后简称为 0512 通则)关于 HPLC 转 UHPLC 的规定进行合规转换。结果显示 UHPLC 方法下,麻黄、黄芩苷和连翘苷的线性关系良好,相关系数 r≥0.999,回收率在 95%-100% 之间,方法学验证结果符合接受标准,含量测定结果与 HPLC 基本一致。与常规 HPLC 方法相比,UHPLC 的方法可以大幅缩短分析时间,提高分析效率,且减少溶剂消耗,绿色环保。

     

    Abstract: To establish a method conversion between HPLC and UHPLC for determination of three main components(ephedra, baicalin, and phillyrin) in Xiao'er Feire Kechuan Keli. According to the regulations on HPLC to UHPLC conversion in section 0512 of the 2020 Pharmacopoeia Part IV General Principles, compliance conversion was carried out. Under the UHPLC method, the linear relationship of ephedra, baicalin, and phillyrin was good, with a correlation coefficient (r) ≥ 0.999 and the recovery between 95% and 100%. The methodological validation results met the acceptance criteria, and the determination results were basically consistent with HPLC. Compared with conventional HPLC methods, the UHPLC method can significantly shorten analysis time, improve analysis efficiency, and consume less solvent, make environmentally friendly.

     

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