中国药物评价2025，Vol.42Issue(4)：281-284,4.
超高效液相色谱-质谱法测定盐酸决奈达隆中遗传毒性杂质的研究
Determination of Genotoxic Impurities in Dronedarone Hydrochloride by UHPLC-MS/MS
摘要
Abstract
Objective:To establish a method for determining the residual amounts of three genotoxic impurities in dronedarone hydro-chloride drug substance using UPLC-MS/MS.Methods:The analysis was performed on a Waters ACQUITY UPLC BEH C18 column(2.1 mm × 50 mm,1.7 μm)at 30 ℃,with a mobile phase consisting of 0.1％formic acid aqueous solution(A)and acetonitrile(B)under gradient elution at a flow rate of 0.3 mL·min.The three genotoxic impurities were detected via electrospray positive ionization(ES+)mode and selected ion recording(SIR)scanning.Results:All three impurities exhibited excellent linearity within the ranges of 20.13-805.1 ng·mL-1(Impurity Ⅰ),62.15-776.9 ng·mL-1(Impurity Ⅱ),and 5.081-813.0 ng·mL-1(Impurity Ⅲ),with correla-tion coefficients(r)of 1.000、1.000 and 0.999.The average recoveries at different concentrations were 93.0％-99.4％(ImpurityⅠ),83.5％-91.7％(Impurity Ⅱ),and 82.0％-92.9％(Impurity Ⅲ).Conclusion:The method is simple to operate,with accu-rate and stable results,high sensitivity,and a wide linear range,meeting the requirements for sample determination.It provides methodo-logical support for the quality control of dronedarone hydrochloride.关键词
超高效液相色谱-质谱法/盐酸决奈达隆/遗传毒性杂质/残留量Key words
UPLC-MS/MS/Dronedarone hydrochloride/Genotoxic impurities/Residue determination分类
医药卫生引用本文复制引用
李筱玲,张丽婷,杨涵,植建琼,黄少莲,曲峥,孙冰月..超高效液相色谱-质谱法测定盐酸决奈达隆中遗传毒性杂质的研究[J].中国药物评价,2025,42(4):281-284,4.基金项目
重202407001肿瘤追踪精准栓塞微球的研制及临床应用关键技术研究(KJZD20240903095704006) （KJZD20240903095704006）
