RP-HPLC测定头孢克肟的含量

Determination of Cefixime by RP-HPLC

关键词:  头孢克肟  含量测定  反相高效液相色谱法

Key words:  cefixime  content determination  RP-HPLC

摘要:

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Hypersil BDS C18 (4.6 mm×250 mm，10 μm)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。

Abstract:

OBJECTIVE To establish a method for the determination of cefixime by RP-HPLC. METHODS Cefixime was separated on a Hypersil BDS C18 column (4.6 mm×250 mm, 10 μm) with a mixture of 0.1 mol·L-1 ammonium acetate (adjusted with ammonia solution to pH 7.0) and acetonitrile (96∶4) as mobile phase. The flow rate was 1.0 mL·min-1. The detection wavelength was 254 nm. The column temperature was 35 ℃. RESULTS The calibration curve was linear within the range of 102.38-1 433.45 μg·mL-1 for cefixime (r=0.999 9). The limit of detection and limit of quantitation were 0.18 ng and 0.60 ng respectively . Statistical analysis by t-test showed no significant differences between the results obtained by the method and by BP 2008. CONCLUSION This method is simple and selective for the determination of cefixime.