硝呋太尔工作参照品的含量测定

Determination of working reference standard of Nifuratel

目的 建立测定硝呋太尔参照品含量的方法。方法 用国外参考品及传递测定方法进行。通过C1 8色谱柱反相分离 ,分别用流动相乙腈 - 0 2 %碳酸铵 (36∶6 4 ) ,二极管阵列检测器 (DAD)和流动相乙腈 -水 (4 0∶6 0 )及激光蒸发光检测器 (ELSD)测定硝呋太尔及相关物质的含量。结果 传递测定硝呋太尔含量为 99.6 %。DAD法为 99.9% ,RSD =0 .1 3% ;ELSD法为1 0 0 .0 % ,RSD =0 .4 7%。结论 两种测定方法 ,能互相印证 ,结果准确可靠 。

OBJECTIVE To establish an HPLC method to determine the content of the working reference standard of Nifuratel.METHODS Foreign Nifuratel reference standard was determined with foreign method through transferred determination, which contrasted to two new ways. ODS column and RP-HPLC were used in both ways to separate Nifuratel and the related substances , but one used DAD detector with mobile phase consisting of acetonitrile-0.02% ammonium carbonate (36∶64), and the other used ELSD detector with acetonitrile-water (40:60)as mobile phase.RESULTS The result of transferred determination is 99.6%. The result of DAD method is 99.9% and RSD =0.13%, and that of ELSD method is 100.0%, RSD =0.47%.CONCLUSION The method was sensitive, accurate and reliable. It can be used in quality control of reference standard of Nifuratel.