摘要
目的:建立头孢特仑新戊酯有关物质检查的HPLC方法。方法:采用C18柱,以醋酸-醋酸钠缓冲液(pH5.0)-乙腈-水(20∶50∶30)为流动相,检测波长为254nm,流速1.0mL/min。结果:本品与各杂质峰达到了很好的分离。杂质Ⅰ、杂质Ⅱ、杂质Ⅲ、杂质Ⅳ、杂质Ⅴ的检测限分别为0.016μg/ml、0.012μg/ml、0.035μg/ml、0.043μg/ml、0.063μg/ml。按确定的方法测定本品三批,有关物质量分别为0.24%、0.26%、0.24%。结论:本法简便可靠,可用于头孢特仑新戊酯有关物质的检查。
Objeetive： To establish a method for testing the related substances in eefteram pivoxil by HPLC. Methods： Using a C18 column; the mobile phase is （acetic acid-sodium acetate buffer solution, pH5.0）-aeetonitrile-water （20：50：30）; deteetlng wavelength is 254nm and flow rate is 1.0mL/min. Results： Good resolution between eefteram pivoxil and impurities were obtained. Five main impurities, Ⅰ, Ⅱ, Ⅲ, Ⅳ and Ⅴ, whose LOD are separately 0.016μg/ml, 0.012μg/ml, 0.035μg/ml, 0.043μg/ml and 0.063μg/ml. Tested three batches of sample using assured method and the whole impurities of them are 0.24%, 0.26%, 0.24%. Conclusion： The simple and accurate method is suitable for detecting related substances in eefteram pivoxil.
出处
《内蒙古中医药》
2011年第16期54-55,共2页
Inner Mongolia Journal of Traditional Chinese Medicine
