摘要
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.
出处
《海峡药学》
2014年第3期51-53,共3页
Strait Pharmaceutical Journal
关键词
盐酸普罗哌酮片
有关物质
含量
HPLC
Propafenone Hydrochloride Tablets
HPLC
Related substances
Assay