Abstract: A impurity detection method of latamoxef sodium is configured to detect the impurities in latamoxef sodium for injection by using high performance liquid chromatography. A chromatographic condition is as follows: taking Agilent ZORBAX SB-CN cyano bonded silica gel column as a stationary phase, taking 0.005˜0.015 mol/L ammonium acetate solution-methanol as a mobile phase A; taking 0.02˜0.03 mol/L ammonium acetate solution-acetonitrile as a mobile phase B; adjusting a pH value of the ammonium acetate solution to 5.8˜6.5; the present disclosure has advantages of a simple operation, high column efficiency, a moderate tailing factor and a retention time of a main peak, high detection accuracy of strong alkali damage, effective separation between the main peak and each impurity peak without interference, which is conducive to accurately controlling quality of lyophilized powder of latamoxef sodium for injection and ensuring quality of drugs.

Abstract: A impurity detection method of latamoxef sodium is configured to detect the impurities in latamoxef sodium for injection by using high performance liquid chromatography. A chromatographic condition is as follows: taking Agilent ZORBAX SB-CN cyano bonded silica gel column as a stationary phase, taking 0.005˜0.015 mol/L ammonium acetate solution-methanol as a mobile phase A; taking 0.02˜0.03 mol/L ammonium acetate solution-acetonitrile as a mobile phase B; adjusting a pH value of the ammonium acetate solution to 5.8˜6.5; the present disclosure has advantages of a simple operation, high column efficiency, a moderate tailing factor and a retention time of a main peak, high detection accuracy of strong alkali damage, effective separation between the main peak and each impurity peak without interference, which is conducive to accurately controlling quality of lyophilized powder of latamoxef sodium for injection and ensuring quality of drugs.