注射用美罗培南有关物质HPLC方法优化

Optimization of HPLC method for related substances of Meropenem for injection

目的改善注射用美罗培南有关物质的高效液相色谱法分离度及峰型问题。方法色谱柱Waters XBridge C_(8)(4.6 mm×250 mm,5μm),以0.1%三乙胺溶液[量取三乙胺1.0 ml,加水900 ml,用磷酸溶液(1→10)调节pH为5.0,加水稀释至1000 ml]-乙腈(94.5∶5.5)为流动相,流速1.5 ml/min,波长:220 nm。结果在优化后的色谱条件下,主成分与各已知杂质分离度良好,美罗培南开环物及二聚体峰型有所改善。结论本法简便、准确、可靠,专属性强,可用于注射用美罗培南的有关物质测定。

Objective To improve the resolution and peak pattern of HPLC method for the determination of related substances of Meropenem for injection.Methods HPLC analysis was performed on an Waters XBridge C_(8)(4.6 mm×250 mm,5μm),with a mobile phase of 0.1%Triethylamine solution(dissolve 1.0 ml triethylamine in 900 ml water,adjust pH to 5.0 with phosphoric acid solution(1→10),then dilute to 1000 ml with water)-acetonitrile(94.5:5.5)at a flow rate of 1.5 ml/min.The detection wavelength was 220 nm.Results Under the optimized chromatographic conditions,the resolution of principal components from known impurities was good,and the peak patterns of meropenem open ring and dimer were improved.Conclusion The method is simple,accurate and reliable,with high specificity for determination of Meropenem for injection and its related substances.