头孢泊肟酯干混悬剂含量及有关物质测定的HPLC方法的建立和验证(英文)

Development and validation of an HPLC method for the determinat ion of cefpodoxime proxetil and its related substances in dry syrups

本文建立了一种在同一色谱条件下同时测定头孢泊肟酯干混悬剂含量及有关物质的 HPL C方法 ,并对其进行了方法学验证。以 Kromasil 10 0 -5C18(2 50 mm× 4.6mm,5μm)为色谱柱 ;0 .0 2 mol/ L乙酸铵 -乙腈 (60∶ 40 ,V/ V)为流动相 ;流速为1.0 ml/ min;检测波长 2 3 5nm;柱温为室温。结果表明 ,方法专属性良好 ;头孢泊肟酯在 12 5～ 875μg/ ml(r=0 .9995,n=7)及相关物质 2 .5～ 17.5μg/ ml (r=0 .9992 ,n=7)的浓度范围内呈线性 ;最低检出限 (L OD)为 0 .3 8μg/ ml;最低定量限 (L OQ)为 1.2 6μg/ ml;方法在高、中、低三个浓度下的平均回收率 (n=3 )及日内 (n=3 )、日间 (n=5)精密度良好 ;样品溶液于 4℃保存时 5d内稳定。

An HPLC method for the determination of ce fp odoxime proxetil and its related substances in dry syrups was developed and vali dated. Cefpodoxime proxetil and its related substances were separated using a mobile phase consisting of acetonitrile∶0.02mol/L ammonium acetate (40∶60, V /V) at a flow rate of 1.0ml/min on a Kromasil C 18 column and detected at U V wavelength 235nm. The method validation included accuracy, precision, spec ificity, LOD, LOQ, linearity as well as stability of the analyte solution. All r esults were shown to be acceptable.