CHINESE JOURNAL OF DRUG EVALUATION >

2026 , Vol. 43 >Issue 3: 184 - 184-188

DOI: https://doi.org/10.2095-3593.2026.060001

Research on the Determination Method and Risk Assessment of Aristolochic Acid Ⅰin Xinfang Biyan Capsules

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  • Henan Institute for Drug and Medical Device Control (Henan Vaccine Issuance Center)，Henan Province Engineering Research Center of Quality Control of Traditional Chinese Medicine， Henan Zhengzhou 450018， China

Received date: 2026-01-12

  Revised date: 2026-04-22

  Accepted date: 2026-08-05

  Online published: 2026-08-12

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Abstract

Objective： To establish an high performance liquid chromatography-mass spectrometry method for the determination of aristolochic acid Ⅰ in xinfang biyan capsules， and provide theoretical basis for its safety control. Methods：Waters ACQUITY UPLC HSS T3 (2.1 mm×100 mm， 1.8 μm) column was used. Methanol-0.1% formic acid (containing 1 mmol·L-1 ammonium acetate) solution was used as mobile phase， gradient elution， flow rate of 0.3 mL·min-1， positive ion mode of electric spray ion source， multi reaction monitoring， external standard determination. Results： The linear relationship of aristolochic acid I was good within the range of 0.320 9-32.092 5 μg·mL-1 (r2=0.999 5)， with an average recovery rate of 95.04%. Aristolochic acid I was detected in all 104 batches of samples， with a content of 7.91-90.75 ng·g-1. Conclusion： This method is sensitive， accurate， reliable， and highly specific， and can be used for the limited detection of aristolochic acid I in xinfang biyan capsules.

Key words： ; font-size:medium; "> ; Xinfang biyan capsules； Aristolochic acid Ⅰ； Safety； High performance liquid chromatography-mass spectrometry； Limit test

Cite this article

RU Qingguo, LI Haiyan, LIU Yanan, JIANG Ludi, HUANG Xia, WANG Haibo . Research on the Determination Method and Risk Assessment of Aristolochic Acid Ⅰin Xinfang Biyan Capsules[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2026 , 43(3) : 184 -184-188 . DOI: 10.2095-3593.2026.060001

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