摘要
目的:建立测定卡托普利中杂质F含量的方法。方法:采用HPLC法,色谱条件:采用手性柱CHIRALCEL OX-H柱;以正己烷-异丙醇(含0.1%三氟乙酸)(80∶20)为流动相;流速:1.0 mL·min^(-1);于215nm处检测。结果:卡托普利和杂质F在此条件下分离度良好,分离度大于1.5。结论:经方法学验证,本法可用于对卡托普利中杂质F的质量控制。
Objective:To establish an HPLC method for determination of impurity F in captopril.Methods:The test was performed in a CHIRALCEL OX-H column under the isocratic elution of n-hexane and isopropanol(containing 0.1%trifluoroacetic acid)(80∶20).The flow rate was 1.0 mL·min^(-1),and the UV detection wavelength was 215 nm.Results:Captopril and impurity F were separated well under the chromatographic condition and the resolution was more than 1.5.Conclusion:The methodology validation results show that the established method can be suitable for control of impurity F in captopril.
作者
吴华
李春香
陈正
林泉松
李杰
WU Hua;LI Chunxiang;CHEN Zheng;LIN Quansong;LI Jie(Chongqing Kerui Pharmaceutical(Group)Co.,Ltd.,Chongqing 400060,China)
出处
《中国药品标准》
CAS
2021年第3期276-278,共3页
Drug Standards of China
