高效液相色谱法测定头孢克肟的含量

Determination of cefixime by HPLC

目的建立测定头孢克肟含量的高效液相方法。方法采用高效液相色谱法,色谱条件:色谱柱为Waters Symmetry C18柱(150 mm×4.6,3.5μm),流动相为磷酸盐缓冲液(0.025 mol/L磷酸二氢钾溶液用磷酸调pH至3.6)-乙腈(90︰10);流速为1.0 mL/min;柱温35℃;检测波长254 nm。结果头孢克肟在25.19~503.80μg/mL浓度范围内,峰面积与浓度呈良好的线性关系(r=1.0000);头孢克肟检测限为6.64μg,定量限为22.14μg;平均回收率为99.22%(n=9),相对标准偏差(RSD)为0.5%。含量测定结果与按《中国药典》2015年版法定标准方法测定结果比较差异无统计学意义(P>0.05)。结论高效液相色谱法简便、可靠,专属性强,可用于头孢克肟的含量测定。

Objective To establish a method for the determination of cefixime by high performance liquid chromatography(HPLC).Methods HPLC method was used to detect the cefixime.Cefixime was separated on a Waters Symmetry C18 column(150 mm×4.6,3.5μm)with Phosphate buffer(0.025 mol/L Potassium dihydrogen phosphate solution was adjusted with phosphoric acid to pH 3.6)and acetonitrile(90︰10)as mobile phase.The flow rate was 1.0 mL/min.The detection wavelength was 254 nm.The column temperature was 35℃.Results The calibration curve was linear within the range of 25.19-503.80μg/mL for cefixime(r=1.0000).The limit of detection and limit of quantitation were 6.64μg and 22.14μg,respectively.The average recovery was 99.22%(n=9),RSD=0.5%.Statistical analysis by t-test showed no significant differences between the results obtained by HPLC and by ChP 2015(P>0.05).Conclusion This method is simple,reliable and selective for the determination of cefixime.