碘帕醇注射液有关物质考察

Determination of the Related Substances in Iopamidol Injection

目的:建立高效液相色谱方法测定碘帕醇注射液的有关物质。方法:采用ZORBAX SB-phenyl色谱柱(250 mm×4.6 mm,5μm),以乙腈-水为流动相进行梯度洗脱,流速为2.0 ml·min^(-1),检测波长240 nm,柱温:40℃,进样量:20μl。结果:本方法能将碘帕醇与其有关物质完全分离,且能精确测定各有关物质的含量。结论:碘帕醇注射液有关物质方法的建立,为碘帕醇原料及其注射液质量控制提供一定的参考依据。

Objective:To establish an HPLC method for the determination of specific impurities in iopamidol injection.Methods:The HPLC separation was performed on a ZORBAX SB-phenyl column(250 mm×4.6 mm,5μm)with gradient elution by the mobile phase consisting of acetonitrile and water.The flow rate was 2.0 ml·min^(-1),the detection wavelength was at 240 nm,the column temperature was 40℃,and the injection volume was 20μl.Results:The method could separate iopamidol and its related substances,and determine the contents of the related substances accurately.Conclusion:The established method is effective for the determination of the specific impurities in iopamidol injection,which provide reference for the quality control of iopamidol and its injection.