HPLC测定氯雷他定的含量及其有关物质  

Determination of Content and Related Substances of Loratadine by HPLC

作　　者：唐立超[1] 郭伟斌[1] 郑淑凤[1] 黄剑英[1] 李玲玲[1] 

机构地区：[1]厦门市药品检验所,福建厦门361012

出　　处：《中国现代应用药学》2014年第8期994-997,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：厦门市重大科技项目(3502Z20121035)

摘　　要：目的建立高效液相色谱法测定氯雷他定含量及其5种有关物质。方法采用AgilentTC—Cl8色谱柱（250mm×4．6mm，5μm），以乙腈-2％冰醋酸溶液为流动相，梯度洗脱，流速为1．0mL·min^-1，检测波长为276nm。结果氯雷他定及其5种杂质分离良好。氯雷他定、地洛他定、N-甲基地洛他定、三环酮、杂质F、杂质I分别在3．2～106．7，0．97～58.3，0．59～35．5，0．58～34．5，0．59～35．4，0．82～49．3P．g·mL^-1内线性关系良好（r=0．9994～0．9999）。结论本方法准确、灵敏、可靠，可用于氯雷他定原料药和制剂的质量研究和质量控制。OBJECTIVE To establish an HPLC method for the determination of the content and related substances of loratadine. METHODS Agilent TC-Cls column was used, the mobile phase consisted of acetonitrile-2% acetic acid solution, gradient elution. The flow rate was 1.0 mL.min-1. The detection wavelength was 276 nm. RESUTLS Loratadine and its impurities could be separated with a good resolution. Loratadine, deslorata, N-methyldesloratadine, tricyclic ketone, impurity Fand I were linear in the range of 3.2-106.7, 0.97-58.3, 0.59-35.5, 0.58-34.5, 0.59-35.4, 0.82-49.3μg·mL-l（r=0.999 4-0.999 9）. CONCLUSION With good accuracy, sensitivity and reliability, the method can be applied to quality research and quality control of loratadine and its preparations.

关 键 词：氯雷他定 有关物质 含量测定 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学]