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目的建立测定头孢克肟含量的反相高效液相色谱法。方法采用HypersilBDS C_(18)(4.6mm×250mm,10μm)色谱柱,流动相为0.1 mol·L~(-1)醋酸铵缓冲液(用氨试液调pH为7.0)-乙腈(96:4),流速1.0 mL·min~(-1),检测波长254 nm,柱温35℃。结果头孢克肟浓度在102.38～1 433.45 μg·mL~(-1)内,峰面积与浓度呈良好线性关系(r=0.999 9);头孢克肟的最低检测限为0.18 ng,最低定量限为0.60 ng,含量测定结果与按BP 2008年版法定标准方法测定结果没有显著性差异。结论本法简便、专属性强,可用于头孢克肟含量的测定。
Objective To establish an RP-HPLC method for the determination of cefixime. Methods A Hypersil BDS C 18 (4.6 mm × 250 mm, 10 μm) column was used. The mobile phase consisted of 0.1 mol·L -1 ammonium acetate buffer (adjusted to pH 7.0 with ammonia solution) and acetonitrile (96: 4 ), The flow rate was 1.0 mL · min ~ (-1), the detection wavelength was 254 nm and the column temperature was 35 ℃. Results The concentration of cefixime was in the range of 102.38-1 433.45 μg · mL -1 with a good linear relationship (r = 0.999 9). The minimum detectable limit of cefixime was 0.18 ng, the lowest limit of quantification was 0.60 ng, the content determination results and the BP 2008 edition of the statutory standard method determination results no significant difference. Conclusion This method is simple, specific and can be used for the determination of cefixime.