Simultaneous Determination of Lovastatin and Lovastatin Acid in Fermentum Rubrum and Zhibituo Tablets by QAMS

HAO Sheng-yuan; WANG Lei; LI Hong; ZHANG Di; XU Hui

doi:10.13422/j.cnki.syfjx.2017050074

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Simultaneous Determination of Lovastatin and Lovastatin Acid in Fermentum Rubrum and Zhibituo Tablets by QAMS

更新时间：2024-01-04

- Simultaneous Determination of Lovastatin and Lovastatin Acid in Fermentum Rubrum and Zhibituo Tablets by QAMS
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 23, Issue 5, Pages: 74-78(2017)
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- DOI：10.13422/j.cnki.syfjx.2017050074
  CLC： R927
- Published：2017
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HAO Sheng-yuan, WANG Lei, LI Hong, et al. Simultaneous Determination of Lovastatin and Lovastatin Acid in Fermentum Rubrum and Zhibituo Tablets by QAMS[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(5): 74-78.
DOI：

HAO Sheng-yuan, WANG Lei, LI Hong, et al. Simultaneous Determination of Lovastatin and Lovastatin Acid in Fermentum Rubrum and Zhibituo Tablets by QAMS[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(5): 74-78. DOI： 10.13422/j.cnki.syfjx.2017050074.

摘要

目的：建立适用于红曲及其制剂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RP-HPLC法，以洛伐他汀为内标物，测定其与洛伐他汀酸的相对校正因子，建立可同时定量检测2种成分的一测多评方法。采用不同的HPLC仪器和色谱柱，验证所建立方法的耐用性，并与外标法测定结果比较，以验证一测多评法的准确性。结果：洛伐他汀酸和洛伐他汀的相对校正因子（relative correction factor，RCF）耐用性良好，6批红曲药材和3批脂必妥片中洛伐他汀酸含量的一测多评法测定结果均与外标法无显著性差异。结论：该研究建立了准确、快速且耐用性良好的洛伐他汀酸和洛伐他汀同时定位定量的一测多评方法，为红曲及其制剂质量标准的进一步完善提供了可靠依据。

Abstract

Objective: To develop a method for quantitative analysis of multiple-components by single marker (QAMS) for simultaneous determination of lovastatin and lovastatin acid in Fermentum Rubrum and its preparations.Method: Lovastatin was used as the internal reference substance

and the relative correction factor (RCF) of lovastatin acid was determined by RP-HPLC. Then the QAMS method was established for simultaneous determination of the two components. The durability of the established method was verified with varying HPLC instrument and chromatographic columns. Then the accuracy of the QAMS method was evaluated by comparing the contents of lovastatin acid with those obtained by the external standard method.Result: The RCF value showed good durability for both lovastatin and lovastatin acid. There were no significant differences between the quantitative results of QAMS method and external standard method.Conclusion: An accurate

rapid and highly durable QAMS method has been developed for simultaneous determination the contents and locations of lovastatin and lovastatin acid

so as to provide reliable basis for the application of QAMS method in quality control of Fermentum Rubrum and its preparations.

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