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作 者:代敏 吴良发 李柯城 周国平 袁铭铭 DAI Min;WU Liang-fa;LI Ke-cheng;ZHOU Guo-ping;YUAN Ming-ming(Jiangxi University of Chinese medicine,Nanchang 330004,China;Jiangxi Provincial Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang 330029,China)
机构地区:[1]江西中医药大学,江西南昌330004 [2]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029
出 处:《化学工程师》2024年第4期22-25,68,共5页Chemical Engineer
基 金:江西省重点研发计划项目(20203BBGL73215)。
摘 要:目的建立清火胶囊中异牡荆素、异金雀花素的HPLC分析方法。方法采用Waters C_(18)(250×4.6mm,5μm)色谱柱,以乙腈-0.2%磷酸溶液(13.5∶86.5)为流动相等度洗脱,流速1mL·min^(-1),检测波长340nm。结果异牡荆素、异金雀花素分别在0.0323~0.9702μg、0.0083~0.2479μg范围内与峰面积线性关系良好(r=0.9999),平均加样回收率分别为101.59%和98.79%,RSD分别为1.32%和1.68%(n=9);精密度、稳定性、重复性实验结果的RSD均小于1.00%。结论所建立的方法简单、稳定、灵敏,可用于清火胶囊的质量控制。OBJECTIVE To establish a HPLC method for the analysis of isovitexin and isoscoparin in Qinghuo capsules.METHODS HPLC column was Waters C_(18)(250×4.6mm,5μm)with acetonitrile-0.2%phosphoric acid solution(13.5∶86.5)as flow equal elution,the flow rate of 1mL·min^(-1)and the wavelength for detection was 340nm.RESULT Isoexin and isoscoparin had a good linear relationship with peak area in the ranges of 0.0323μg to 0.9702μg and 0.0083μg to 0.2479μg,respectively(r=0.9999).The average recoveries were 101.59%and 98.79%,and RSD were 1.32%and 1.68%(n=9),respectively.RSD of precision,stability and repeatability test results were all less than 1.00%.CONCLUSION The established method is simple,stable and sensitive,and can be used for the quality control of Qinghuo capsules.
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