HPLC法检查氯雷他定及其制剂的有关物质  

Determination of Related Substances in Loratadine and its Preparations by HPLC

作　　者：赵亚萍 

机构地区：[1]湖北省药品检验所,武汉430064

出　　处：《中国药品标准》2003年第3期56-59,共4页Drug Standards of China

摘　　要：目的:采用HPLC法检查氯雷他定及其制剂(片剂、胶囊、颗粒剂)的有关物质。方法:采用Diamonsil C_(18)(5μm,200mm×4.6mm)色谱柱,流动相:乙腈-0.05moL.L^(-1)磷酸二氢铵(用磷酸调pH为2.5)(50:50),检测波长245nm,柱温:40℃,流速:1.0mL.min^(-1) 。结果:在0.125mg·mL^1～1.25mg·mL^(-1)浓度范围内呈良好的线性关系,回归方程Y=1751C+50,相关系数r=0.99998,最低检测浓度80μg.mL^(-1),最低检测量1.6ng。结论:方法简便,快速,准确;可同时分离和测定氯雷定原料及其制剂的有关物质。To establish HPLC method for testing the related substance of Loratadine and its Preparation (tablets, capsule,granules). Methods:Diamonsil C18 column was used(5μm, 200mm× 4. 0mm),acetonitrile-0. 55mol/L ammonia dihy-drogen phosphate (adjusted to pH=3. 0 by phosphoric acid)(50 = 50) as mobile phase,the detection wavelength was 245nm, column temperature was 40℃,the flow rate was 1. 0ml/min. Results: The calibration curves was linear in the concentration range of 0. 125 mg/ml-l. 25mg/ml for. Loratadine. The regression equation;Y= 1751 C+50,r = 0. 99998. Conclution:This method was found to be simple,quick and accurate for testing the related substances of Loratadine and its preparations.

关 键 词：HPLC法 检查 氯雷他定 制剂 抗组织胺药 过敏性皮肤病 有关物质 

分 类 号：R971[医药卫生—药品] R927.1[医药卫生—药学]