现代科学仪器2023，Vol.40Issue(6)：38-41,4.
缬沙坦类药物中相关杂质的LC-MS/MS测定
Determination of related impurities in Valsartan drugs by LC-MS/MS
王玮 1Stephan Altmaier1
作者信息
- 1. 默克化工技术(上海)有限公司,上海 200120
- 折叠
摘要
Abstract
To establish the determination of related impurities in valsartan drugs,separate and determine related impurities of sartan drugs by LC-MS/MS method,and use Discovery ® HS F5,(5μm particle size,L×I.D.15cm×4.6mm)column.Mobile phase A is 0.1%formic acid aqueous solution.The mobile phase B was composed of 0.1%formic acid methanol solution with gradient elution at a flow rate of 0.40 mL/min.The ionization mode was ESI+.Qualitative analysis was performed in multiple reaction monitoring mode(MRM).The detection limit of related impurities in sartan was 10.0μ g/kg by matrix external labeling method.The limit of quantitation was 20.0 μg/kg,and the correlation coefficients were all greater than 0.999 in the linear concentration range of 10-100 μg/L.The standard recoveries were 72.3-86.9%,and the relative standard deviations(RSDs)were 4.7-8.9%.The method has high accuracy and reliability for the detection and analysis results of related substances in sartan drugs,and is suitable for the determination of related substances residues in sartan drugs.关键词
缬沙坦类药物/有关物质/LC-MS/MS/定性与定量Key words
Valsartan drugs/Related Substances/LC-MS/MS/Qualitative&Quantitative引用本文复制引用
王玮,Stephan Altmaier..缬沙坦类药物中相关杂质的LC-MS/MS测定[J].现代科学仪器,2023,40(6):38-41,4.
