HPLC法测定盐酸普罗哌酮片中盐酸普罗哌酮含量与有关物质

Determination of Propafenone Hydrochloride and Related Substances in propafenone Hydrochloride Tablets by HPLC

目的：建立盐酸普罗哌酮片有关物质和含量测定的HPLC测定方法。方法采用C8柱，以0.0015mol· L-1磷酸氢二钾溶液（用磷酸调节pH为2.5）-乙腈（65∶35）为流动相；流速1.0mL· min -1；检测波长为220nm。结果盐酸普罗哌酮片的线性范围为20.07～120.42μg· mL -1（r＝1.0000），平均回收率为99.93％，RSD为0.40％（n＝9），盐酸普罗哌酮片检测限浓度为0.06μg· mL -1。结论方法简便，准确，专属性强，可作为盐酸普罗帕酮片质量检测方法。

OBJECTIVE To establish a method for content determination of Propafenone Hydrochloride Tablets and related substances.METHODS A C8 column was used with the mobile phase of 0.0015 mol · L-1 K2 HPO4-Acetonitrile （65∶35）.The flow rate was 1.0mL· min -1 and the detection wavelength was 220nm.RESULTS The calibration curves of Propafenone Hydrochloride Tablets was linear in the range of 20.07-120.42μg · mL-1 （ r=1.0000 ） ,and the average recovery was 99.93%, RSD was 0.40% （ n =9 ）.The detection limit of Propafenone Hydrochloride Tablets was 0.06μg· mL-1.CONCLUSION The method is rapid,accurate and reliable for content determination of Propafenone Hydrochloride Tablets and related substances.