摘要
目的建立测定头孢克肟有关物质的RP-HPLC方法。方法采用Hypersil BDS C18(4.6mm×250mm,10μm)色谱柱,流动相为0.1mol/L醋酸铵缓冲液(用氨试液调pH为7.0)-乙腈(96︰4),流速1.0mL/min,检测波长254nm,柱温35℃。结果头孢克肟在0.10-49.33μg/mL浓度范围内,峰面积与浓度呈良好线性关系(r=1.0000);最低检测限为0.18ng;各有关物质与主成份均达到基线分离。结论本法简便、专属,可用于头孢克肟有关物质的测定。
Objective To establish a method for the determination of related substances in cefixime by RPHPLC. Methods The chromatographic separation of the related substances was performed on a Hypersil BDS C18 column（4.6mm×250mm, 10μm）with a mixture of 0.1 mol/L ammonium acetate （adjusted with ammonia solution to pH of 7.0） and acetonitrile （96 ： 4） as mobile phase. The flow rate was 1.0mL/min. The detection wavelength was 254nm. The column temperature was 35℃. Results The calibration curve was linear within the range of 0.10-49.33μg/mL for cefixime （r= 1.0000）. The detection limit of cefixime was 0.18ng. The cefixime could be separated effectively from its degradation product with the method. Conclusion This method is simple and selective for the determination of related substances in Cefixime.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2010年第3期209-213,共5页
Chinese Journal of Antibiotics
