HPLC法测定曲匹地尔胶囊及片剂中有关物质的含量  

Content Determination of Related Substances in Trapidil Capsules and Trapidil Tabelts by HPLC

作　　者：闫辉[1] 闫凯[2] 李金凤 

机构地区：[1]北京军区天津疗养院药剂科,天津市300191 [2]河北省药品检验所,石家庄市050011 [3]河北蕾越医药科技有限公司,石家庄市050011

出　　处：《中国药房》2011年第21期1990-1992,共3页China Pharmacy

摘　　要：目的:建立测定曲匹地尔胶囊及片剂中有关物质含量的方法。方法:采用高效液相色谱法。色谱柱:Zorbax EclipseXDB-C18;流动相:乙腈-0.01mo·lL-1醋酸钠溶液=28∶72;检测波长:292nm;柱温:室温;流速:1.0mL·min-1;进样量:20μL。采用主成分自身对照法测定4批制剂中有关物质含量。结果:主成分与有关物质能完全分离,最低检测限为0.16ng,4批制剂中单个杂质含量均小于0.21%,总杂质含量均小于0.59%。结论:所建立的方法专属性强、适用性好、耐用性良好,可用于曲匹地尔胶囊及片剂中有关物质的含量检查。OBJECTIVE：To establish a method for the content determination of related substances in Trapidil capsules and Trapidil tablets.METHODS：HPLC method was adopted.The determination was performed on Zorbax Eclipse XDB-C18 column with mobile phase consisted of acetonitrile-0.01 mol·L-1 sodium acetate solution（28 ∶ 72） at a flow rate of 1.0 mL·min-1.The detection wavelength was set at 292 nm and the column temperature was maintained at room temperature.The injection size was 20 μL.The contents of related substance in 4 batches of samples were determined by self-control method.RESULTS：Related substances were completely separated from main components and the lowest determination limit was 0.16 ng.The content of single impurity was smaller than 0.21% and the contents of total impurities were all smaller than 0.59%.CONCLUSION：The method is specific,feasible and durable,and it is suitable for the determination of related substances in Trapidil capsules and Trapidil tablets.

关 键 词：曲匹地尔 胶囊 片剂 有关物质 高效液相色谱法 含量 

分 类 号：R927.11[医药卫生—药学] R972