HPLC法测定氨溴特罗口服液中两组分的含量和有关物质  

HPLC Determination of Two Components and Related Substances in Ambrocol Oral Solution

作　　者：王雪芹 李云 闻京伟 

机构地区：[1]河南省药品检验所,郑州450003

出　　处：《药物分析杂志》2004年第6期605-608,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:用HPLC法测定氨溴特罗口服液中盐酸克仑特罗和盐酸氨溴索的含量及其有关物质。方法:用Zorbax SB-C18色谱柱(250 mm×4.6 mm,5μm);乙腈-0.05 moL·L-1磷酸二氢钾(含0.2%三乙胺,用磷酸调节pH至3.5)(19:81)为流动相;流速:1.0 mL·min-1;检测波长:245 nm;柱温:30℃;进样量:20μL。结果:盐酸克仑特罗与盐酸氨溴索分别与其相邻杂质峰能完全分离,盐酸克仑特罗在0.1266-506.4μg·mL-1和盐酸氨溴索在1.02-510 μg·mL-1浓度范围内线性关系均良好(r=0.9999)。结论:该法简便、准确、专属性好,可以用于氨溴特罗口服液中盐酸克仑特罗和盐酸氨溴索的含量测定及有关物质检查。WANG Xue - qin, LI Yun and WEN Jing - wei(Henan Provincial Institute for Drug Control, Zhengzhou 450003)sisted of a Zorbax SB - C18 column ( 5μm, 250 mm× 4. 6 mm ) and a mixture of aeetonitrile and 0. 05 moL·L-1 potassium dihydrogen phosphate solution(19: 81 )as mobile phase. The flow rate was 1.0 mL· min-1 with detection wavelength at 245 nm and column temperature at 30℃. Results: Ambroxole hydrochloride and clenbuterol hydro-chloride could be completely separated from other impurities. The linear range of ambroxole hydrochloride was 1. 02 -510μg·mL-1 and clenbuterol hydrochloride was 0. 1266 -506. 4μg· mL-1 (r =0. 9999). Conclusion:The method is simple, accurate and is suitable for the determination of ambroxole hydrochloride and clenbuterol hydro-chloride and related substances in ambrocol oral solution.

关 键 词：HPLC法 测定 氨溴特罗口服液 含量 盐酸克仑特罗 盐酸氨溴索 

分 类 号：R927.2[医药卫生—药学]