应用国产色谱柱测定胺碘酮血浆浓度的研究

Study on determining plasma concentration of Amiodarone using China-made column replacing imported column

本文建立了在进口高效液相色谱仪上应用国产色谱柱取代进口色谱柱测定胺碘酮血浓度的方法。两法的最低检测限均为20ng,血浆中最低有效检测浓度均为0.2μg/ml,日内回收率国产色谱柱法为95.8%,进口色谱柱法为96.5%.日间回收率前法为95.0%,后法为96.7%.两法测定同一血药浓度接近,相关系数为0.999,斜率为0.9852,结果表明国产色谱柱可代替进口色谱柱用于血浆胺碘酮浓度监测。

The method for determining the plasma concentration of amiodarone by the Ch-ina-made column replacing the imported column in HPLC was establishedinthis paper.The detection limits of amiodarone with these two methods were20ng,and the lowest detectible plasma levels were 0.2ug/ml.The recovery ratesin 1 day and 4 days were 95.8%,95.0% by the China-made column,and 96.5%,96.7by the imported column,respectively.The plasma concentration of amiodaronemeasured by these two methods were same.The relative coefficient was 0.9999andthe slope 0.9852.The results showed that the China-made column could replacethe imported column to use for monitoring the plasma concentration of amiodar-one.