中国药科大学学报2025，Vol.56Issue(1)：65-72,8.DOI:10.11665/j.issn.1000-5048.2024062603
卡贝缩宫素注射液有关物质检测方法的建立与验证
Establishment and validation of the determination method for the related substances in carbetocin injection
陈一淼 1张翔 2吴锦慧 1黄玉晔1
作者信息
- 1. 南京大学医学院,南京 210093
- 2. 常州四药制药有限公司,常州 213004
- 折叠
摘要
Abstract
An HPLC analytical method was developed to determine the related substances in carbetocin injection.The method was performed on a Waters Xbridge C18 column(150 mm×3 mm,3.5 μm)with 0.30 mg/mL ammonium acetate-19%acetonitrile aqueous solution as mobile phase A and mobile phase A-acetonitrile(1∶1)as mobile phase B.The detection wavelength was 220 nm.Gradient elution was performed at the flow rate of 0.8 mL/min and the column temperature of 60℃.The method was validated for system applicability,specificity,linearity and range,accuracy,with the results that the 9 impurities of carbetocin injection showed good linearity(R²>0.999)with peak area in their respective concentration range,and that the method had good precision(RSD<5%).This method is suitable for the simultaneous determination of carbetocin and its 9 impurities in carbetocin injection and can provide a theoretical basis for the quality control of the carbetocin injection.关键词
卡贝缩宫素注射液/有关物质/高效液相色谱法Key words
carbetocin injection/related substances/high performance liquid chromatography分类
药学引用本文复制引用
陈一淼,张翔,吴锦慧,黄玉晔..卡贝缩宫素注射液有关物质检测方法的建立与验证[J].中国药科大学学报,2025,56(1):65-72,8.
