摘要
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5.02~60.30μg·m L^(-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 m L。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。
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 system.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.
出处
《中国现代中药》
CAS
2017年第2期205-208,共4页
Modern Chinese Medicine
基金
国家中医药管理局中医药行业科研专项(201307002)
