首页|UPLC-MS/MS法检测正天胶囊中马兜铃酸类成分

UPLC-MS/MS法检测正天胶囊中马兜铃酸类成分

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目的 建立测定正天胶囊中马兜铃酸类成分的分析方法.方法 采用Dikma Endeavorsil C18(1.8 μm,2.1 mm×100 mm)色谱柱,以乙腈和0.1%甲酸-5 mmol甲酸铵溶液为流动相,梯度洗脱,电喷雾正离子(ESI+),多反应监测(MRM),进样量为5 μL,测定正天胶囊中马兜铃酸Ⅰ、马兜铃酸Ⅱ、马兜铃酸Ⅲa、马兜铃酸Ⅳa、马兜铃内酰胺Ⅰ的质量分数.结果 10批样品中检出2种马兜铃酸类物质,质量分数分别为马兜铃酸Ⅳa 0.15~1.03 mg/kg、马兜铃内酰胺Ⅰ0.40~1.51 mg/kg.结论 本研究建立的正天胶囊中马兜铃酸质量分数测定方法,可为正天胶囊及含马兜铃酸中药制剂的临床应用和安全监管提供参考.
Determination of aristolochic acid component in Zhengtian Capsule by UPLC-MS/MS
Objective To establish an analytical method for determining aristolochic acid components in Zhengtian Capsule.Methods The chromatographic column was Dikma Endeavorsil C18(1.8 μ m.2.1 mm×100 mm),and the mobile phase was acetonitrile and 0.1%formic acid 5 mmol ammonium formate solution as mobile phase by gradient elution.Electro spray positive ion mode(ESI+)and multi reaction monitoring(MRM)mode were used for detection,and the injection volume was 5 μL.The content of aristolochic acid I,aristolochic acid Ⅱ,aristolochic acid Ⅲ a,aristolochic acid AA-Ⅳa,and aristolochic lactam I in Zhengtian Capsule was determined.Results Two types of aristolochic acid substances were detected in 10 batches of samples.The content of aristolochic acid AA-IVa was 0.15-1.03 mg/kg,and the content of aristolochic acid lactam I was 0.40-1.51 mg/kg.Conclusion The method for determining the content of aristolochic acid in Zhengtian Capsules established in this study can provide reference for the clinical application and safety supervision of Zhengtian Capsules and traditional Chinese medicine preparations containing aristolochic acid.

Zhengtian Capsulearistolochic acid componentUPLC-MS/MS

刘珍、张万青、陈佩文、刘潇潇

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广东省药品检验所,广东广州 510663

正天胶囊 马兜铃酸类成分 液相色谱串联质谱法

广东省药品监督管理局科技创新项目

S2022YDZ065

2024

广东药科大学学报
广东药学院

广东药科大学学报

CSTPCD
影响因子:0.698
ISSN:1006-8783
年,卷(期):2024.40(2)
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