【摘要】 目的　用改良的高效液相色谱法测定卡托普利片含量和有关物质。方法　采用DiamonsilC18( 15 0mm× 4 .6mm 5 μm)色谱柱 ,流动相 :乙腈 :0 .0 5 %磷酸水溶液 =2 6∶74 ,柱温 4 0℃ ,流速 1.0mL/min ,检测波长 2 2 0mm ,按峰面积外标法计算。结果　卡托普利在 5 .0 4～ 15 0 μm/mL范围内和卡托普利二硫化物在 1.5 12～ 4 5μm/mL范围内线性良好 ,卡托普利线性方程为 ρ =14 .36A - 10 .80 (r =0 .9998,n =5 ) ,卡托普利二硫化物线性方程为 ρ =15 .81A - 10 .0 2 (r =0 .9996 ,n =5 ) ,加样回收率为 99.5 8～ 10 1.83% (n =5 ) ,日内、日间RSD <2 .10 % (n =5 )。卡托普利最低检出浓度为 0 .17μg/mL ,卡托普利二硫化物为 0 .4 5 μg/mL。测得几个厂家的样品含量均合格 ,但有差异 ;有关物质二硫化物的含量小于 3% ,均合格。结论　本方法简便 ,快速 ,结果准确 ,可靠 ,重现性好更多还原

【Abstract】 Purpose To develop a high performance liquid chromatography to determine the content and related substance of Captopril. Methods The HPLC separation was carried out on a DikmaC 18 (4.6 mm×150 mm,5 μm)Column,using a UV detector and the wavelength was 220 nm,with acetonitril-0.05% phosphoric acid solution (52∶48) as the mobile phase.The temperature of the colum was 40℃. Results Two good linearity were demonstrated by linear equation ρ =14.36 A -10.80( r =0.9998, n =5)of Captopril and ρ =15.81 A -10.02( r =0.9996, n =5)of bisulfide of Captopril.The intra day and inter day deviation was showed by RSD%<2.09%.The limit of detection of the Captopril was 0.17 μg/mL and the bisulfide of Captopril was 0.45 μg/mL.All the samples are qualified. Conclusions The method was proved to be accurate,sensitive and reliable.更多还原