Content determination of six arsenic species in Daqili preparations by HPLC-ICP-MS

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Author: Liang-Fa WU Yi WU Zhi-Qiang ZHOU  Jun-Hua JIANG

Affiliation: Jiangxi Institute for Drug Control, NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine, Jiangxi Province Engineering Research Center of Drug and Medical Device Quality, Nanchang 330029, China

Keywords: HPLC-ICP-MS Daqili preparations Arsenic species Inorganic arsenic Safety

DOI: 10.19960/j.issn.1005-0698.202310006

Reference: Liang-Fa WU, Yi WU, Zhi-Qiang ZHOU, Jun-Hua JIANG.Content determination of six arsenic species in Daqili preparations by HPLCICP-MS[J].Yaowu Liuxingbingxue Zazhi,2023, 32(10):1127-1134.DOI: 10.19960/j.issn.1005-0698.202310006.[Article in Chinese]  Copied

Abstract
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Abstract

Objective To determine the contents of arsenic betaine (AsB), arsenic choline (AsC), monomethyl arsenic (MMA), dimethyl arsenic (DMA), arsenite (As Ⅲ) and arsenate (As V) in Daqili preparations and conduct safety evaluation.

Methods The samples were extracted by ultrasonography using artificial intestinal fluid in a 37℃ water bath, determined by HPLC-ICP-MS. The chromatographic conditions: Hamilton PRP-X100 anion exchange column (250 mm× 4.1 mm, 10 μm), the gradient elution was performed with the mixture of 100 mmol·L^-1 ammonium carbonate and 2% methanol in a gradient elution as mobile phase at a flow rate of 0.8 mL·min^-1.

Results The limits of detection of the method were 2.00-6.00 μg·kg^-1, and the linear ranges were within the range of 1-200 ng·mL^-1, with the correlation coefficients greater than or equal 0.999 8. The recoveries were between 96.15% and 101.76%, with the relative standard deviations less than 2% (n=6). That arsenic in Daqili preparations mainly existed in the form of inorganic arsenic with high toxicity, and As V had the highest content, followed by As Ⅲ. AsB, AsC, MMA and DMA were not detected, and the potential health safety risk was high.

Conclusion The established method is accurate and reproducible, which can provide reference for evaluating the safety of Daqili preparations. It was suggested that inorganic arsenic (As Ⅲ, As V) should be used as the toxicity limit index of Daqili preparations.

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