CAJ | 학술논문

目的：建立注射用美罗培南有关物质的测定方法。方法：采用HPLC法，0.1%三乙胺溶液∶乙腈（93.5∶6.5）为流动相，检测波长为220nm，柱温为40℃。结果：美罗培南开环物（杂质A）、美罗培南、美罗培南二聚体（杂质B）间的分离度良好，纯度系数均大于0.99。结论：该方法简便、专属性强、重现性好，可用于注射用美罗培南的杂质检查。
목적：건립주사용미라배남유관물질적측정방법。방법：채용HPLC법，0.1%삼을알용액∶을정（93.5∶6.5）위류동상，검측파장위220nm，주온위40℃。결과：미라배남개배물（잡질A）、미라배남、미라배남이취체（잡질B）간적분리도량호，순도계수균대우0.99。결론：해방법간편、전속성강、중현성호，가용우주사용미라배남적잡질검사。
Objective:To establish a method for determining related substance in meropenem for injection.Methods: Using the method of HPLC ,the mobile phase was 0.1% three triethylamine solution∶acetonitrile (93.5∶6.5), the detective wavelength was 220 nm and the column temperature Was 40℃.Results: Meropenem was completely separated from impurity A and impurity B,the purity coefficient is greater than 0.99. Conclution: The method is sensitive,specific,accurate and reliable,it is suitable to the determination of related substance in meropenem for injection.