论文部分内容阅读
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。本文建立的方法也适合于头孢泊肟酯原料药的分析
In this paper, a HPLC method for the simultaneous determination of cefpodoxime proxetil suspension and its related substances by HPL C under the same chromatographic conditions was established. The column was eluted with Kromasil 10 0 -5 C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.02 mol / L ammonium acetate-acetonitrile (60:40, V / V) ; Detection wavelength of 23 5nm; column temperature is room temperature. The results showed that the method was of good specificity. Cefpodoxime proxetil was active in the range of 125 to 875 μg / ml (r = 0.9995, n = 7) and related substances 2.5 to 17.5 μg / ml (r = 0.9992, n = 7) was linear over the concentration range; the lowest detection limit (LOD) was 0.38 μg / ml; the lowest limit of quantitation (L OQ) was 1.2 6 μg / ml; The average recoveries (n = 3) and days (n = 3) were good during the day (n = 5). The sample solution was stable within 5 days at 4 ℃. The method established in this paper is also suitable for the analysis of cefpodoximes APIs