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目的:建立当药高效液相色谱(HPLC)特征图谱的质量评价方法。方法:采用Waters 2695-2996型高效液相色谱仪,Dionex Ultimate 3000型高效液相色谱仪,Agilent~(-1)260型高效液相色谱仪;资生堂CAPCELL PAK C18MGⅡ色谱柱(4.6 mm×250 mm,5μm),波士顿Green ODS色谱柱(4.6 mm×250 mm,5μm),菲罗门Gemini 5μC18110A色谱柱(4.6 mm×250 mm),以甲醇-乙腈-0.05 mol·L~(-1)磷酸二氢钠溶液(0.1%磷酸溶液调节p H至3.9)(15∶5∶80)为流动相,检测波长268 nm,流速1.0 m L·min~(-1)。采用主成分相对保留时间比较分析法,对10批不同产地的当药HPLC特征图谱进行评价。结果:建立了当药的HPLC特征图谱,共标定了5个共有峰,10批当药共有峰的相对保留时间的RSD<2.0%。结论:该研究建立的当药特征图谱特征性和专属性强,且方法快速、简便、可靠,可用于控制当药的质量。
Objective: To establish a method for quality assessment of high performance liquid chromatography (HPLC) profiles. Methods: A Waters 2695-2996 high performance liquid chromatograph, a Dionex Ultimate 3000 high performance liquid chromatograph, an Agilent ~ (-1) 260 high performance liquid chromatograph and a Shiseido CAPCELL PAK C18MG Ⅱ column (4.6 mm × 250 mm , 5 μm), Boston Green ODS column (4.6 mm × 250 mm, 5 μm), and Phenomenex Gemini 5μC18110A column (4.6 mm × 250 mm) Sodium hydrogen solution (0.1% phosphoric acid solution adjusted to pH 3.9) (15:5:80) was used as the mobile phase at a detection wavelength of 268 nm and a flow rate of 1.0 mL · min -1. The comparative analysis of the relative retention time of the main components was used to evaluate the HPLC profiles of the crude drugs from 10 batches of different producing areas. Results: The HPLC chromatogram of the drug was established. Five common peaks were identified. The relative retention time (RSD) of common peak of 10 batches of drug was less than 2.0%. Conclusion: This study established the characteristic map of the medicinal characteristics and its specificity, and the method is rapid, simple and reliable and can be used to control the quality of the medicinal herbs.