UPLC法测定消炎止咳胶囊中的穿心莲内酯和脱水穿心莲内酯的含量
Determination of Andrographolide and Dehyandrographolide in Xiaoyan Zhike CapsuLes by UPLC Method
金昭 1刘志海 1彭啟丽 1王丹丹1
作者信息
- 1. 贵州省黔西南州检验检测中心,贵州 兴义 562400
- 折叠
摘要
目的:建立消炎止咳胶囊中穿心莲内酯和脱水穿心莲内酯的超高效液相色谱(ultra performance liquid chromatography,UPLC)含量测定方法,提高该制剂质量控制标准.方法:采用UPLC含量测定方法.色谱条件:BEH C18(2.1mm × 150mm,1.7μm)为分离柱;流动相为乙腈-水,梯度洗脱;穿心莲内酯检测波长为225 nm,脱水穿心莲内酯检测波长为254 nm;柱温为30 ℃;流速0.3 mL/min,进样体积2 μL.结果:穿心莲内酯在13.0775～130.7748 μg/mL范围内呈良好的线性关系(R2=0.9999,n=5);加样回收率为97.4％,RSD值为1.3％.脱水穿心莲内酯在12.47129～124.7129 μg/mL范围内呈良好的线性关系(R2=0.9999,n=5);加样回收率为102.3％,RSD值为1.2％.对10批消炎止咳胶囊进行含量测定,穿心莲内酯含量测定结果为2442.34～2683.48 μg/g,脱水穿心莲内酯的含量测定结果为1551.43～1834.64μg/g,二者的总含量测定结果为3995.91～4672.18μg/g.结论:采用UPLC对消炎止咳胶囊中的穿心莲内酯和脱水穿心莲内酯的成分进行含量测定,该方法专属性强、重复性好、简单高效、准确可靠,可用于该制剂的质量控制.
Abstract
Objective To establish a Ultra Performance Liquid Chromatography(UPLC)method for the determination of androgra-pholide and dehyandrographolide in Xiaoyan Zhike Capsules,and enhance the quality control standard of the preparation.Methods The UPLC content determination method was used.Chromatographic conditions:BEH C18(2.1 mm × 150 mm,1.7 μm)was used as the separation column;the mobile phase was acetonitrile-water with gradient elution;the detection wavelength of andrographolide was 225 nm,and the detection wavelength of dehyandrographolide was 254 nm;the column temperature was 30 ℃;the flow rate was 0.3 ml/min,and the injection volume was 2 μL Results Andrographolide The linear range was 13.0775-130.7748 μg/mL(R2=0.9999,n=5),and the spiked recoveries were 97.4％with the RSD value of 1.3％.Dehyandrographolide showed good linear rela-tionship within the range of 12.47129-124.7129 μg/mL(R2=0.9999,n=5);the spiked recoveries were 102.3％and the RSD value was 1.2％.The content of 10 batches of Xiaoyan Zhike Capsules was determined,and the results of andrographolide were 2442.34-2683.48 μg/g,the results of dehydrated dehyandrographolide were 1551.43-1834.64 μg/g,and the results of the total content of the two were 3995.91-4672.18 μg/g.Conclusion UPLC was used for the content determination of andrographolide and dehyandrographolide in Xiaoyan Zhike Capsules.The method is exclusive,reproducible,simple,efficient,accurate and reliable,and can be used for the quality control of this preparation.
关键词
消炎止咳胶囊/穿心莲/穿心莲内酯/脱水穿心莲内酯/UPLCKey words
Xiaoyan Zhike Capsules/Andrographis PanicuLata/Andrographolide/Dehyandrographolide/UPLC引用本文复制引用
出版年
2025
NETL
NSTL
万方数据