盐酸普罗帕酮片及注射液的HPLC测定  

Determination of Propafenone Hydrochloride Tablets and Injection by HPLC

作　　者：邵泓[1] 汪洁[1] 

机构地区：[1]上海市药品检验所,上海200233

出　　处：《中国医药工业杂志》2001年第10期463-465,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了测定盐酸普罗帕酮片及注射液含量与有关物质的 HPL C法。采用 Shim - pack CL C ODS色谱柱 ,流动相为乙腈 - 0 .0 1mol/ L磷酸氢二铵溶液 (2∶ 1,用磷酸调节 p H值至 4.6 ) ,检测波长为 2 46 nm。线性范围为 30～ 2 70μg/ ml,相关系数为 0 .9999,片剂和注射液的平均回收率分别为 10 1.4% (RSD =1.4% )和 10 1.3% (RSD =0 .96 % ) ;盐酸普罗帕酮、环氧酚和 AK- 2 6的最低检出量分别为 0 .3、0 .17和 0 .39ng。A HPLC method for the determination of propafenone hydrochloride tablets and injection was established. A Shim pack CLC ODS column was used, with the mobile phase of acetonitrile 0.01 mol/L diammonium hydrogen phosphate solution(2∶1, adjust the pH to 4.6 by phosphoric acid), at the detection wavelength of 246 nm. The linear range of propafenone hydrochloride was 30~270 μg/ml with r = 0.9999 . The average recoveries of tablets and injection were 101.4%( RSD =1.4%) and 101.3%( RSD = 0.96 %), respectively. The detective limits of propafenone hydrochloride, epoxifenone and AK 26 were 0.3 ,0.17 and 0.39 ng, respectively.

关 键 词：盐酸普罗帕酮 有关物质 测定 HPLC 

分 类 号：R972.2[医药卫生—药品] R914.1[医药卫生—药学]