HPLC法测定头孢噻肟钠的有关物质

Determination of Related Substances of Cefotaxime Sodium by HPLC

建立对头孢噻肟钠有关物质的检测方法。使用安捷伦C18色谱柱,以pH6.2的磷酸氢二钠缓冲液-乙腈作为流动相。235 nm的检测波长,30℃的柱温,4℃的进样室温度,1.0 mL·min^(-1)的流速,10μL的进样量。能够对头孢噻肟钠有关物质进行准确的定性和定量。测试结果表明,杂质A、杂质B、杂质C、杂质D、杂质E、杂质F、杂质G、杂质H、杂质7-ACA、杂质J检测限分别为0.0078、0.0151、0.0126、0.0053、0.0108、0.0054、0.0201、0.0129、0.0214、0.0140μg·mL^(-1),定量限分别为0.0266、0.0514、0.0430、0.0188、0.0359、0.0180、0.0674、0.0431、0.0715、0.0472μg·mL^(-1),浓度线性范围0.0180~16.614μg·mL^(-1)内线性关系较好,相关系数≥0.999;回收率在90%~108%范围内。该方法具有较强专属性、灵敏度高且耐用性好,能够满足检测要求。

A detection method for related substances of cefotaxime sodium was established by using Agilent C18 column with pH=6.2 disodium hydrogen phosphate buffer-acetonitrile as the mobile phase.The detection wavelength was 235 nm,the column temperature was 30℃,the inlet room temperature was 4℃,the flow rate was 1.0 mL·min^(-1),and the injection volume was 10μL.Accurate qualitative and quantitative analysis of cefotaxime sodium related substances was realized.The results showed that the detection limits for impurities A,B,C,D,E,F,G,H,7-ACA and J were 0.0078,0.0151,0.0126,0.0053,0.0108,0.0054,0.0201,0.0129,0.0214,0.0140μg·mL^(-1),the limits of quantification were 0.0266,0.0514,0.0430,0.0188,0.0359,0.0180,0.0674,0.0431,0.0715,0.0472μg·mL^(-1),the concentration linear range was 0.0180~16.6140μg·mL^(-1),and the linear relationship was good,the correlation coefficient was≥0.999;the average recoveries were within the range of 90%~108%.The method has strong specificity,high sensitivity and good durability,which can meet the inspection requirements.