HPLC校正因子法同时测定葛根素及其各种注射剂中的5种有关物质  

Simultaneous quantification of five impurities in puerarin and its injections by HPLC method with correction factor

作　　者：陈蕊[1] 陈民辉[2] 蔡梅[2] 王玉[1,2] 

机构地区：[1]中国药科大学药物分析教研室,江苏南京210009 [2]江苏省药品检验所,江苏南京210008

出　　处：《中国中药杂志》2011年第13期1744-1750,共7页China Journal of Chinese Materia Medica

基　　金：国家"十一五"科技支撑计划项目(2006EAI14B01)

摘　　要：目的:建立校正因子法测定葛根素及其注射剂中5种有关物质的含量。方法:采用高效液相色谱法,以葛根素为参照物质,建立葛根素及其注射剂中5种有关物质(有关物质A,B,C,D,E)的相对校正因子,并用相对校正因子对葛根素及其注射剂中相应的有关物质进行定量分析,同时与有关物质对照品法测定的结果进行比较,以验证方法的准确性。结果:用校正因子法测定38批葛根素及其注射剂中5种有关物质的含量与外标法测定的结果无显著性差异。结论:本法能够准确测定葛根素及其注射剂中有关物质A,B,C,D,E的含量。Objective： To establish a HPLC method with the relative correction factors（RCFs） for quantification of five critical related substances（A,B,C,D and E） in puerarin and its injection.Method：Taking puerarin as the internal standard,corresponding RCFs of the critical related substances were determined respectively.According to their RCFs,simultaneous determination of five related substances in puerarin and its injection was performed.The method was evaluated by comparison the quantitative results of external standard method and the method with RCFs correction.Result： There were no significant differences in the results of five critical related substances in 38 batches of puerarin and its injection by external standard method and the method with RCFs correction.Conclusion： The HPLC method with RCFs was validated to be accurate and can be successfully applied to determine the critical related substances in puerarin and its injection.

关 键 词：高效液相色谱法 相对校正因子 葛根素 有关物质 含量测定 

分 类 号：R284.1[医药卫生—中药学]