HPLC法测定盐酸度洛西汀肠溶片的有关物质与含量  

Assay and Test for Related Substances of Duloxetine Hydrochloride Enteric-coated Tablets by HPLC

作　　者：施友铃[1] 沙吉达[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《中国药事》2007年第9期720-722,共3页Chinese Pharmaceutical Affairs

摘　　要：采用高效液相色谱法测定盐酸度洛西汀肠溶片的含量与有关物质。色谱柱：Thermo ODS-2HYPERSIL;流动相：乙腈-0.05 mol·L^-1醋酸胺溶液（55∶45,用三乙胺调节pH值至9.0）;流速：1.0 mL·min^-1;检测波长：230 nm。结果在2.5～25μg·mL^-1范围内线性关系良好（r=0.9999,n=6）,平均回收率为98.7%,RSD为1.5%。本法专属性强、灵敏、准确,可用于盐酸度洛西汀的含量及有关物质的测定。A HPLC method was established for the determination of Duloxetine Hydrochloride Enteric -coated Tablets and its Related Substances. The chromatogram columniation were Thermo ODS- 2HYPERSIL. Acetonitrile- 0.05 mol·L^-1 Ammonium acetate （55： 45, pH = 9.0 adjusted by Triethylamine） was mobile phase. The flow rate was 1.0 mL·min^-1. The detection was carried out with an ultraviolet detector at 230 nm. The standard curve was linear in the range of 2.5～25μg·mL^-1. The average recovery was 98.7%, RSD was 1.5%. The method is sensitive and accurate. It can be used for the quantitative determination of Duloxetine Hydrochloride Enteric-coated Tablets and its Related Substances.

关 键 词：HPLC 盐酸度洛西汀 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]