Objective:To establish a method for determination of rosmarinic acid in Lycopi Herba and provide research data for Lycopi Herba monograph recommended to European Pharmacopeia(EP).Methods:An HPLC method was established by optimizing different extraction and chromatographic conditions and totally validated.Meanwhile,One-variable-at-a-time (OVAT)method was applied in the robustness test,and dwell volume of the HPLC system was determined following the described method in EP.Results:It was shown that the method kept good linearity(r =0.999 9)in the concentration range of 5.02-60.30 μg·mL-1 for rosmarinic acid.The recovery was in the range of 95.5％-101.6％ with RSD value of 2.1％.RSDs of repeatability,intermediate precision,stability and robustness test were less than 3.0％,and the dwell volume was determined as 2.4 mL for the HPLC systern Conclusion:The method is simple,accurate and reliable with good repeatability and robustness,which could be selected as determination method of rosmarinic acid for the draft of Lycopi Herba monograph recommended to EP.%目的:建立泽兰中迷迭香酸的含量测定方法,为《欧洲药典》泽兰专论的质量标准提供研究数据.方法:采用高效液相色谱法.基于样品提取和色谱条件的优化结果建立迷迭香酸的分析方法,同时对该方法进行系统的方法学验证,包括采用单变量分析(OVAT)进行方法的耐用性研究及按照《欧洲药典》的方法测定该色谱系统的滞留体积.结果:迷迭香酸检测质量浓度线性范围为5.02 ～60.30 μg· mL-1(r =0.999 9);加样回收率为95.5％～101.6％,RSD =2.1％(n=9);重复性、中间精密度、稳定性及耐用性试验的RSD均小于3.0％;该色谱系统滞留体积为2.4 mL.结论:该方法操作简单,重复性、准确度及耐用性良好,可作为泽兰中迷迭香酸的含量测定方法列入《欧洲药典》泽兰专论的质量标准草案.
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