头孢哌酮乳房注入剂有关物质HPLC方法的建立及应用OA

To effectively analyze the related substances in cefoperazone intramammary infusion and provide scientific basis for the quality control and process optimization of the formulation,a specific,sensitive,rapid,and simple method for the determination of related substances in cefoperazone intramammary infusion was established according to the quality standard of cefoperazone sodium for injection.The method employed high-performance liquid chromatography(HPLC)with an ultraviolet detector.The separation was performed on an Agilent Eclipse XDB-C18 column(150 mm×4.6 mm,5 μm)atacolumntemperatureof40℃.Themobilephaseconsistedof water,acetonitrile,and triethylamine in a volume ratio of 880∶120∶6,adjusted to pH3.0±0.2 with glacial acetic acid.The flow rate was 1 mL/min,the detection wavelength was 254 nm,and the injection volume was 20 μL.The content of related substances in cefoperazone intramammary infusion(lactating period)was calculated using the self-contrast method.The precision,linearity,and specificity of the method were investigated.Under extreme stress conditions,the content of related substances,the degradation degree of the main component peak area,and the number of impurities were compared before and after degradation.The results showed that the drug concentration was linearly correlated with the peak area after a series of gradient dilutions of cefoperazone intramammary infusion.Cefoperazone intramammary infusion degraded under strong acid,strong base,high temperature,and oxidative stress conditions.The retention times of the main component peak and the related substance peaks remained consistent before and after degradation.The separations between the main peak and impurity peaks,as well as between impurity peaks,were good,with resolutions all greater than 1.5.The established method for the determination of related substances in cefoperazone intramammary infusion is simple,specific,and reproducible,and is suitable for the determination of related substances in cefoperazone intramammary infusion.