Safety Monitoring

Detection of 37 compounds illegally added in Yixintong tablets by ultra- high performance liquid chromatography-tandem mass spectrometry*

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  • 1. National Institutes for Food and Drug Control, Beijing 100050, China;
    2. Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China

Received date: 2021-01-08

  Online published: 2024-06-21

Abstract

Objective: To develop a method based on ultra-high-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS) for the simultaneous detection of 37 compounds illegally added in Yixintong tablets as an example. Methods: The samples were separated on the UPLC HSS T3 C18(100 mm×2.1 mm, 1.8 μm) chromatographic column by gradient elution using 0.1% formic acid and acetonitrile as the mobile phase. The electrospray ion source was operated in both the positive and negative ion mode using the multi-reaction monitoring(MRM) method, and the results were quantified by the external standard method. Results: The correlation coefficients(R2) of the linear calibration curves were greater than 0.99 in the corresponding mass concentration ranges, and the limits of quantification(LOQs) for the analytes were 3-10 μg·L-1. The average recoveries ranged from 63.4% to 138.3%. Among the 37 compounds to be tested in 78 samples of 46 batches, no other compounds were detected except aspirin. The content of aspirin was 0.847-3.261 μg per tablet, the content was very low and had no significance of illegal addition. Conclusion: The established method is sensitive, rapid, accurate, reliable, and applicable for the detection of the illegal addition of antipyretic and analgesic affect compounds in Yixintong tablets.

Cite this article

ZUO Tian-tian, ZHANG Lin-lin, JIN Hong-yu, WANG Dan-dan, FANG Cui-fen, MA Lin-ke, CHEN Bi-lian, ZAN Ke, MA Shuang-cheng . Detection of 37 compounds illegally added in Yixintong tablets by ultra- high performance liquid chromatography-tandem mass spectrometry*[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(10) : 1739 -1747 . DOI: 10.16155/j.0254-1793.2021.10.11

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