摘要
目的:建立HPLC法测定注射用替卡西林钠克拉维酸钾有关物质的方法。方法:采用氰基硅烷键合硅胶(4.6mm×250mm,5μm)色谱柱;流动相:0.1mol/L磷酸二氢钠溶液(pH=3.25)-异丙醇(97.5:2.5);检测波长:230nm;流速:1.0ml/min。结果:各杂质峰与主峰分离度良好,克拉维酸的最小检测限为0.193μg/ml,替卡西林的最小检测限为0.355μg/ml。结论:本方法可用于注射用替卡西林钠克拉维酸钾的有关物质检测,且方法简便快速、准确可靠。
Objective：To establish a method for determination Ticarcillin disodium and Potassium Clavulanate for Injection by HPLC.Methods：The Macherey-nagel（4.6 mm×250 mm,5 μm） column was used.The mobile phases consisted of 0.1mol/L-sodium dihydrogen phosphate（pH=3.25） and propanol（75：25）,the detection wavelength was 230 nm and the flow rate was 1.0 ml/min.Results：Impurities were separated well from the main constituents,and the detection limit of potassium clavulanate was 0.193 μg/ml and the detection limit of ticarcillin disodium was 0.355 μg/ml.Conclusion：This method is suitable for the quality of Ticarcillin disodium and Potassium Clavulanate for Injection,and the method is simple,rapid,accurate.
出处
《中国医药导报》
CAS
2010年第21期49-50,共2页
China Medical Herald
关键词
替卡西林钠
克拉维酸钾
有关物质
Ticarcillin disodium
Potassium Clavulanate
Related substances
