【摘要】 目的　探讨建立测定头孢克肟胶囊的含量及其有关物质的反相高效液相色谱分析方法。方法　HPLC色谱系统为C18柱 (2 5 0mm× 4 .6mm ,5 μm) ;流动相 :以乙腈 / pH7.0四丁基氢氧化铵溶液 (取 0 .4mol/L四丁基氢氧化铵溶液 2 5ml,用水稀释至 10 0 0ml,用 1.5mol/L的磷酸调节pH值至 7.0 ) (2 2 5 / 775 ,v/v) ;检测波长 :2 5 4mm ;流速 :1.0ml/min ;室温操作。结果头孢克肟在浓度为 175 5 .5～ 87.8μg/L范围内 ,与峰面积呈良好的线性关系 (r =0 .9999)。平均回收率为 99.4 9% ,RSD为 0 .4 0 %。测得的 3个批号胶囊的头孢克肟含量分别为 97.39%、97.96 %、98.13% ;其有关物质含量分别为 0 .6 2 %、0 .5 2 %、0 .95 %。结论　本法试剂易得 ,样品处理简便 ,分析快速准确 ,重现性好 ,可以作为头孢克肟胶囊剂的含量及有关物质测定方法。更多还原

【Abstract】 Objective To establish RP-HPLC method for the de te rmination of cefixime and its related substances in its capsules.Methods Cefixime was separated on ODS column(250 mm× 4.6 mm,5 μm) with a m ixture of 0.25% tetrabutylammonium hydroxide solution adjust with 1.5 mol/L phos phoric acid to a pH of 7.0 and acetonitrile(775:225,v/v)as mobile phase and dete cted at 254 nm wave length,the flow rate was 1.0 ml/min.The column temperature w as R.T.Results The standard curve was linear in the concentration r ange1755.5～87.8μg/L and the correlation coefficient was 0.9999.The average rec overy rates was 99.49%, RSD was 0.40%.Three batches capsule’s content are 97.39% 、97.96%、98.13%.Conclusion The methods are simple, rapid, accurate , and reliable.The agents are easy obtained and be used as to determine the cont ent of cefixime and its related substances in preparation.更多还原