HPLC法测定盐酸普罗帕酮片的含量

Determination of Propafenone Hydrochloride Tablet by HPLC

目的:建立HPLC法用于盐酸普罗帕酮片的含量测定。方法:采用Aglient ASB-C C_(18)色谱柱(250 mm×4.6 mm,5μm),以0.015 mol/L磷酸氢二钾(用磷酸调节至pH 2.5)-乙腈(65∶35)为流动相;流速:1.0 mL/min;检测波长:248 nm;柱温:30℃。结果:盐酸普罗帕酮在20～75μg/mL范围内线性关系良好(r=0.9998,n=5),回收率为100.24%,RSD为0.719%(n=9)。结论:该方法简便、快捷,准确度高,可用于盐酸普罗帕酮片的质量控制。

Objective To establish HPLC method for the determination of propafenone hydrochloride tablets.Methods The Aglient ASB-C C18 column(250 mm×4.6 mm,5μm)was used as analytical column,the mobile phase consisted of 0.015 mol/L potassium dihydrogen phosphate aqueous solution(adjusted pH to 2.5 by phosphoric acid)-acetonitrile(65∶35).The flow rate was 1.0 mL/min.The ultraviolet detection wavelength was at 248 nm,and column temperature was 30℃.Result propafenone hydrochloride showed a good linearity within the range of 20~75μg/mL(r=0.9998,n=5).The recoveries was 100.24%with RSD 0.719%(n=9).Conclusion The method was simple,convenient and had high accuracy.It can be used for the quality control of propafenone hydrochloride tablets.