首页|UPLC-MS/MS测定双辛鼻窦炎颗粒中马兜铃酸Ⅰ和马兜铃酸Ⅱ的含量

UPLC-MS/MS测定双辛鼻窦炎颗粒中马兜铃酸Ⅰ和马兜铃酸Ⅱ的含量

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目的:同时测定双辛鼻窦炎颗粒中马兜铃酸Ⅰ和马兜铃酸Ⅱ的含量,为其质量控制提供参考.方法:采用超高效液相色谱-质谱法(UPLC-MS/MS)同时测定双辛鼻窦炎颗粒中马兜铃酸Ⅰ和马兜铃酸Ⅱ的含量.采用 Waters ACQUITY UPLC HSS T3 色谱柱(100 mm×2.1 mm,1.8 μm),乙腈(A)-0.1%甲酸水溶液(含 1 mmol·L-1 乙酸铵,B)为流动相梯度洗脱,电喷雾离子源,正离子扫描,多反应监测模式,以标准曲线法计算样品中马兜铃酸Ⅰ和马兜铃酸Ⅱ的含量.结果:12 批双辛鼻窦炎颗粒中 9 批样品未检出马兜铃酸Ⅰ(检出限0.13 pg),3 批样品检出马兜铃酸Ⅰ,质量分数为 14.62～25.82 ng·g-1.所有样品均未检出马兜铃酸Ⅱ(检出限0.44 pg).结论:建立的UPLC-MS/MS同时测定双辛鼻窦炎颗粒中马兜铃酸Ⅰ和马兜铃酸Ⅱ含量的方法,专属性强、灵敏度高、重复性好,可为双辛鼻窦炎颗粒中马兜铃酸Ⅰ和马兜铃酸Ⅱ的质量控制提供参考.
Determination of Aristolochic Acid Ⅰ and Aristolochic Acid Ⅱ in Shuangxin Bidouyan Granules by UPLC-MS/MS
Objective:To simultaneously determine the content of aristolochic acid Ⅰ and aristolochic acid Ⅱ in Shuangxin Bidouyan Granules,and provide a reference for their quality control.Methods:Ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)was used to simultaneously determine the content of aristolochic acid Ⅰ and aristolochic acid Ⅱ in Shuangxin Bidouyan Granules.A Waters ACQUITY UPLC HSS T3 column(100 mm×2.1 mm,1.8 μm)was used with a gradient elution of acetonitrile(A)and 0.1%formic acid in water(containing 1 mmol·L-1 ammonium acetate,B)as the mobile phase.An electrospray ionization(ESI)source in positive ion multiple reaction monitoring mode was employed.The content of aristolochic acid Ⅰ and aristolochic acid Ⅱ in the samples were calculated using the standard curve method.Results:Among 12 batches of Shuangxin Bidouyan Granules,aristolochic acidⅠ was not detected in 9 batches(detection limit 0.13 pg),while it was detected in 3 batches with a mass fraction ranging from 14.62 to 25.82 ng·g-1.Aristolochic acid Ⅱ was not detected in any of the samples(detection limit 0.44 pg).Conclusion:The established UPLC-MS/MS method for the simultaneous determination of aristolochic acid Ⅰ and aristolochic acid Ⅱ in Shuangxin Bidouyan Granules is highly specific,sensitive,and reproducible.This method provides a reference for the quality control of aristolochic acid Ⅰ and aristolochic acid Ⅱ in Shuangxin Bidouyan Granules.

Shuangxin Bidouyan Granulesaristolochic acid Ⅰaristolochic acid ⅡUPLC-MS/MScontent determine

郭日新、肖萌、刘静、戴忠、魏锋

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中国食品药品检定研究院,北京 100050

双辛鼻窦炎颗粒 马兜铃酸Ⅰ 马兜铃酸Ⅱ 超高效液相色谱-质谱法 含量测定

国家药品监督管理局药品监管科学体系建设重点项目中国食品药品检定研究院关键技术研究子课题国家药品标准制修订研究课题药品监管科学全国重点实验室课题

RS2024Z006GJJS-2022-7-1-52022Z162023SKLDRS0102

2024

10.13313/j.issn.1673-4890.20240417001

中国现代中药
中国中药协会,中国医药集团总公司,中国药材公司

中国现代中药

CSTPCD
影响因子：0.65
ISSN：1673-4890
年,卷(期)：2024.26(8)