高效液相色谱法测定那格列奈含量及其有关物质  

Determination of nateglinide and its related substances by HPLC

作　　者：何笑荣[1] 胡欣[1] 闫小燕[1] 曹国颖[1] 邹定[1] 

机构地区：[1]卫生部北京医院,北京100730

出　　处：《中国医院药学杂志》2005年第1期51-53,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的:采用高效液相色谱法(HPLC)测定那格列奈原料、片剂、胶囊的含量及相关物质检查方法。方法:采用SymmetryC18 色谱柱(4.6mm×250mm,5μm);以乙腈 磷酸盐溶液(每1000mL水含磷酸二氢钾4.08g,用磷酸调节pH2.8)(41∶59)为流动 相;流速:1.0mL·min-1;检测波长:214nm,柱温:室温;进样量:10μL。结果:在该色谱条件下,那格列奈在49～295mg·L-1范围 内呈良好线性关系,r=0.9999(n=6),平均回收率为99.5%,RSD为1.4%,检测限为7μg·L-1。结论:该方法简便、准确,可作为 那格列奈含量及有关物质的测定方法。OBJECTIVE A HPLC method was established for the determination of nateglinide,its prepara tions and related substances.METHODS The separation was performed on Symmetry C 18 column( 4.6 mm× 250 mm , 5 μm).The mobile phase consisted of acetonitrile-monobasic sodium pho sphate solution (41∶59),adjusted to pH 2.8 with phosphoric acid.The f low rate was 1.0 mL·min -1.The detection wavelength was 214 n m.The chromatography was conducted at room temperature, 10 μL were inject ed.RESULTS There ...

关 键 词：高效液相色谱法 那格列奈 含量 有关物质 

分 类 号：R927.2[医药卫生—药学]