PLC法同时测定福辛普利钠片中福辛普利钠及其降解产物福辛普利拉的含量

Simultaneous determination of fosinopril sodium and fosinoprilat in fosnopril sodium tablets by HPLC

目的 :建立同时测定福辛普利钠片中福辛普利钠及其降解产物福辛普利拉的高效液相色谱法。方法 :以 μ BondapakC18( 3 0 0× 4 .6mm ,1 0 μm)为分析柱 ,0 .8%三乙胺溶液 (用磷酸调节pH3 .0 ) 乙腈 ( 3 5∶65)为流动相 ,检测波长 :2 1 5nm ,峰面积内标法。结果 :回收率与线性范围分别为 (n =5) :福辛普利钠 ( 1 0 0 .3 % ,RSD =0 .3 7% ,50～2 50 μg/ml) ;福辛普利拉 ( 1 0 1 .8% ,RSD =0 .67% ,2 .5～ 1 2 .5μg/ml)。 结论 :本法简便 ,适合福辛普利钠片中福辛普利钠及其降解产物福辛普利拉的含量测定。

OBJECTIVE:To establish a HPLC method for the simultaneous determination of fosinopril sodium and fosinoprilat in fosinopril sodium tablets.METHODS:A colum of μ Bondapak C 18 (300×4.6mm,10μm) was used with mobile phase of 0.8% triethylamine(pH=3.0) acetonitrile(35∶65) and detected at 215nm,the internal standard was.RESULTS:The recoveries,preaision and liner ranges for:fosinopril sodium were 100.3%,RSD=0.37%,n=5,50～250μg/ml respectirely and these for fosinoprilat were 101.8%,RSD=0.67% n=5,2.5～12.5μg/ml,respectively.CONCLUSION:The method is suitable for the determination of fosinopril sodium and fosinoprilat in fosinopril sodium tablets.