反相高效液相色谱测定氨溴特罗口服溶液中盐酸克仑特罗的研究  

Content Determination of Clenbuterol Hydrochloride in Ambroxol Oral Solution by RP-HPLC

作　　者：陈雁[1] 肖望书 李旭 CHEN Yan;XIAO Wang-shu;LI Xu(Yangzhou Polytechnic College,Yangzhou 225009,China;Yangzhou NO.3 Pharmaceutical Co.,Ltd,Yangzhou 225231,China)

机构地区：[1]扬州职业大学,江苏扬州225009 [2]扬州市第三制药有限公司,江苏扬州225231

出　　处：《扬州职业大学学报》2024年第2期51-55,共5页Journal of Yangzhou Polytechnic College

基　　金：扬州职业大学高等教育科学研究课题(2023GJ14)。

摘　　要：建立氨溴特罗口服溶液中盐酸克仑特罗成分含量测定的方法并开展方法学验证。采用ZORBAX SB-C18色谱柱,流动相为磷酸二氢钾溶液-甲醇,检测波长244 nm,柱温40℃,流速1.0 mL·min^(-1),进样量10μL。结果显示,盐酸克仑特罗在0.0511~0.4099μg·mL^(-1)范围内线性关系良好;平均回收率(n=9)为100.0079%,RSD为1.57%。测得盐酸克仑特罗含量为标示量的98.96%,符合药典标准。The purpose of the experiment was to establish a method for the determination of clenbuterol hydrochloride in ambroterol oral solution and to validate the method.The chromatographic column was ZORBAX C_(18),the mobile phase was monopotassium phosphate solution-Methanol,the detection wavelength was 244 nm,the column temperature was 40℃,the flow rate was 1.0 mL/min,and the injection volume was 10μL.Results showed that clenbuterol hydrochloride had a good linear relationship in the range of 0.0511μg/mL to 0.4099μg/mL.The average recovery(n=9)was 100.0022%with the RSD of 1.55%.The content of clenbuterol hydrochloride was 98.96%of the labeled amount,which met the pharmacopoeia standard.

关 键 词：高效液相色谱法 氨溴特罗口服溶液 盐酸克仑特罗 含量测定 

分 类 号：R927.2[医药卫生—药学]