超高效液相-质谱法测定滴通鼻炎水中马兜铃酸Ⅰ、Ⅱ的含量

doi:10.19803/j.1672-8629.20230740

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (4): 386-390.
DOI: 10.19803/j.1672-8629.20230740

超高效液相-质谱法测定滴通鼻炎水中马兜铃酸Ⅰ、Ⅱ的含量

郭日新, 肖萌, 刘静^*, 戴忠, 马双成

中国食品药品检定研究院中药民族药检定所,北京 100050

收稿日期:2023-11-28 出版日期:2024-04-15 发布日期:2024-04-18
通讯作者: ^*刘静,女,博士,研究员,中药质量控制与中药标准物质。E-mail：liujing_zsm@126.com
作者简介:郭日新,女,硕士,助理研究员,中药质量控制与中药标准物质。
基金资助:
国家科技重大专项重大新药创制（2018ZX09735-006）; 2022年度国家药品标准制修订研究课题（2022Z16）; 国家药品监督管理局药品监管科学体系建设重点项目（RS2024Z006）

Content determination of aristolochic acid Ⅰ and aristolochic acid Ⅱ in Ditong Biyan Shui by UPLC-MS/MS

GUO Rixin, XIAO Meng, LIU Jing^*, DAI Zhong, MA Shuangcheng

Institute for Control of Chinese Traditional Medicine and Ethnic Medicine, National Institutes for Food and Drug Control, Beijing 100050, China

Received:2023-11-28 Online:2024-04-15 Published:2024-04-18

摘要/Abstract

摘要： 目的测定滴通鼻炎水中马兜铃酸Ⅰ、马兜铃酸Ⅱ的含量,为其质量控制提供借鉴。方法采用超高效液相-质谱法（UPLC-MS/MS）同时测定滴通鼻炎水中马兜铃酸Ⅰ、马兜铃酸Ⅱ的含量。色谱柱采用Waters-ACQUI UPLC HSS T3 C₁₈（2.1 mm×100 mm,1.8μm）,采用乙腈为流动相A,0.1%甲酸含1 mmol·L^-1乙酸铵溶液为流动相B,梯度洗脱,电喷雾离子源（ESI）,正离子多反应监测模式,以标准曲线法计算含量。结果 17批滴通鼻炎水中有9批样品未检出马兜铃酸Ⅰ（检出限0.13 pg）,8批样品中检出马兜铃酸Ⅰ,含量在0.41~3.60 ng·mL^-1。所有样品中均未检出马兜铃酸Ⅱ（检出限0.41 pg）。结论建立了UPLC-MS/MS同时测定滴通鼻炎水中马兜铃酸Ⅰ、马兜铃酸Ⅱ含量的方法,该方法专属性强、灵敏度高、重复性好,可为滴通鼻炎水中马兜铃酸Ⅰ、马兜铃酸Ⅱ的质量控制提供参考。

关键词: 滴通鼻炎水, 马兜铃酸Ⅰ, 马兜铃酸Ⅱ, 超高效液相-质谱法, 含量测定

Abstract: Objective To determine the contents of aristolochic acid I and aristolochic acid Ⅱ in Ditong Biyan Shui, and to provide reference for quality control. Methods A UPLC-MS/MS method was established to determine the contents of aristolochic acid I and aristolochic acid Ⅱ. An Waters-ACQUI UPLC HSS T3 C₁₈(2.1 mm×100 mm, 1.8 μm) was used as the chromatographic column. The mobile phase was eluted with acetonitrile (A), 0.1% formic acid solution (B) using a gradient elution method. The electrospray spray ion source (ESI) and positive ion multi-reaction monitoring mode were adopted. The contents were calculated using the standard curve method. Results Aristolochic acid I was not detected in 9 samples of 17 batches of Ditong Biyan Shui (detection limit 0.13 pg), but was detected in 8 batches of samples, with the contents ranging from 0.41 to 3.60 ng·mL^-1. Aristolochic acid Ⅱ was not detected in any of the samples (detection limit 0.41 pg). Conclusion A UPLC-MS/MS method has been established to determine the contents of aristolochic acid I and aristolochic acid Ⅱ in Ditong Biyan Shui, with high specificity, high sensitivity, good repeatability, which can provide reference for quality control of aristolochic acid I and aristolochic acid Ⅱ in Ditong Biyan Shui.

Key words: Ditong Biyan Shui, aristolochic acid I, aristolochic acid Ⅱ, UPLC-MS/MS, content determination

中图分类号:

R927.1

郭日新, 肖萌, 刘静, 戴忠, 马双成. 超高效液相-质谱法测定滴通鼻炎水中马兜铃酸Ⅰ、Ⅱ的含量[J]. 中国药物警戒, 2024, 21(4): 386-390.

GUO Rixin, XIAO Meng, LIU Jing, DAI Zhong, MA Shuangcheng. Content determination of aristolochic acid Ⅰ and aristolochic acid Ⅱ in Ditong Biyan Shui by UPLC-MS/MS[J]. Chinese Journal of Pharmacovigilance, 2024, 21(4): 386-390.

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超高效液相-质谱法测定滴通鼻炎水中马兜铃酸Ⅰ、Ⅱ的含量

Content determination of aristolochic acid Ⅰ and aristolochic acid Ⅱ in Ditong Biyan Shui by UPLC-MS/MS

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