反相高效液相色谱法测定氯苄律定及其有关物质  

RP-HPLC determination of chlorobenzylidine and its related compounds

作　　者：倪坤仪[1] 厉程[2] 王焕云[3] 张灿[1] 黄文龙[1] 

机构地区：[1]中国药科大学,南京210009 [2]江苏省药品检验所,南京210008 [3]内蒙古医学院,呼和浩特010050

出　　处：《中国新药杂志》2001年第5期358-360,共3页Chinese Journal of New Drugs

基　　金：国家新药研究基金 (870 41);国家医药科技创新 10 35项目 95 ED 0 1(K95 12 18)

摘　　要：目的 :建立一种反相高效液相色谱法检查氯苄律定有关物质及测定其含量。方法 :通过调节流动相pH值、三乙胺浓度及甲醇比例 ,确定流动相组成为甲醇 水 三乙胺 (6 5∶35∶0 .4) ,磷酸调节 pH =3 .5 ,检测波长为2 2 5nm。同时考察了方法的专属性和灵敏度。结果 :该法对有关物质的混合试样、粗品、降解产品和多批产品的检查结果表明 ,该法专属性强、灵敏度高。结论Objective:To establish a RP HPLC method for determination of chlorobenzylidine content and its related compounds.Methods:The mobile phase was consisted of methanol∶water∶triethylamine=65∶35∶0.4 and its pH value was adjusted to 3.5 by using phosphoric acid.The wavelength used in determination was 225 nm.The specificity and sensitivity of the method were also studied.Results:The method is shown to be accurate and sensitive by method validation and actural sample analysis.Conclusion:The RP HPLC method recommended in this paper is reliable and effective for testing related compounds in chlorobenzylidine and for its content determination. [

关 键 词：氯苄律定 反相高效液相色谱法 物质检查 抗心律失常药 

分 类 号：R972.2[医药卫生—药品] R917[医药卫生—药学]