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中国精品科技期刊2020
朱映黎,谷洪顺,张建军,等. 一测多评法同时测定红曲茯苓片中洛伐他汀和洛伐他汀酸含量[J]. 食品工业科技,2023,44(14):290−295. doi: 10.13386/j.issn1002-0306.2022080322.
引用本文: 朱映黎,谷洪顺,张建军,等. 一测多评法同时测定红曲茯苓片中洛伐他汀和洛伐他汀酸含量[J]. 食品工业科技,2023,44(14):290−295. doi: 10.13386/j.issn1002-0306.2022080322.
ZHU Yingli, GU Hongshun, ZHANG Jianjun, et al. Simultaneous Determination of Lovastatin and Lovastatin Acid in Hongqu Fuling Tablets by on Quantitative Analysis of Multi—Components by Single Marker(QAMS)[J]. Science and Technology of Food Industry, 2023, 44(14): 290−295. (in Chinese with English abstract). doi: 10.13386/j.issn1002-0306.2022080322.
Citation: ZHU Yingli, GU Hongshun, ZHANG Jianjun, et al. Simultaneous Determination of Lovastatin and Lovastatin Acid in Hongqu Fuling Tablets by on Quantitative Analysis of Multi—Components by Single Marker(QAMS)[J]. Science and Technology of Food Industry, 2023, 44(14): 290−295. (in Chinese with English abstract). doi: 10.13386/j.issn1002-0306.2022080322.

一测多评法同时测定红曲茯苓片中洛伐他汀和洛伐他汀酸含量

Simultaneous Determination of Lovastatin and Lovastatin Acid in Hongqu Fuling Tablets by on Quantitative Analysis of Multi—Components by Single Marker(QAMS)

  • 摘要: 目的:建立适于红曲茯苓片质量控制的洛伐他汀和洛伐他汀酸的一测多评含量测定方法。方法:采用高效液相色谱法,以洛伐他汀为对照,建立与其开环产物洛伐他汀酸的校正因子关系,同时对产品中洛伐他汀和洛伐他汀酸两种成分同时进行定量检测的一测多评方法。结果:阴性样品无干扰,样品检测方法的专属性良好,洛伐他汀和洛伐他汀酸在相应的线性范围内线性关系良好,R2>0.9999,精密度和重复性RSD值均小于3%,加标回收率为在98.43%~103.18%之间。洛伐他汀对洛伐他汀酸的相对校正因子为0.9000;一测多评法测定三批红曲茯苓片中洛伐他汀酸的平均含量为0.3563 mg/g,外标法测定洛伐他汀酸的平均含量为0.3668 mg/g;洛伐他汀的平均含量为1.1113 mg/g,表明所构建的一测多评法可用于红曲茯苓片的多成分质量评价研究。结论:本研究建立的产品中洛伐他汀定量方法稳定准确,专属性强,为以红曲为原料的红曲茯苓片的质量控制和深度开发提供了科学依据。

     

    Abstract: Objective: To establish a quantitative analysis of multi-components by single marker (QAMS) method for the determination of lovastatin and lovastatin acid for the quality control of Hongqu Fuling tablets. Methods: Lovastatin as a control, the RP-HPLC method was used to establish the relationship between the correction factor of lovastatin and lovastatin acid, and to simultaneously quantify both lovastatin and lovastatin acid in the Hongqu Fuling tablets by QAMS. Results: The negative sample had no interference, the specificity of the sample detection method was good, the linear relationship between lovastatin and lovastatin acid was good within the corresponding linear range, R2>0.9999, the precision and repeatability RSD values were less than 3%, and the recovery was 98.43%~103.18%. The relative correction factor of lovastatin acid and lovastatin was 0.9000, and the repeatability was good. The average content of lovastatin acid was 0.3563 mg/g determined by QAMS, and the average content of lovastatin acid determined by external standard method was 0.3668 mg/g, and the average content of lovastatin was 1.1113 mg/g, which indicated that the constructed QAMS method could be used for the multi-component quality evaluation research of Hongqu Fuling Tablets. Conclusion: The QAMS method established in this study was stable, accurate and specific, and would provide a scientific basis for the quality control and in-depth development of Hongqu Fuling tablets.

     

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