反相高效液相色谱法同时测定氨溴特罗口服液中盐酸氨溴索和盐酸克伦特罗的含量

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

目的建立同时测定氨溴特罗口服溶液中盐酸氨溴索和盐酸克伦特罗含量的方法。方法采用RP-HPLC法测定,Agilent C18（4.6mm×250mm,5μm）色谱柱,流动相为乙腈-0.01mol·L-1磷酸二氢钾溶液（加入0.4%三乙胺,用磷酸调p H至3.5）（23∶77）;流速：1.0m L·min-1,检测波长：244nm,柱温35℃;进样量：20μL。结果盐酸氨溴索和盐酸克伦特罗分离良好,盐酸氨溴索在0.28475-2.278mg·m L-1（r=0.9999）盐酸克伦特罗在0.494-247μg·m L-1（r=1）范围内线性良好。结论该法操作简单,耗时较短,可以用于氨溴特罗口服溶液的定量分析。

OBJECTIVE To develop a method for simultaneous determination of ambroxol hydrochloride and clenbuterol hydrochloride in ambroxol and clenbuterol oral solution. METHODS Agilent Cls （4.6mm x 250mm, 5 mn） column, mobile phase consisted of acetonitrile-0. 01 mol · L- 1 potassium dihydrogen phosphate solution （23 ： 77）, the flow rate was 1.0mL · min-1 with detection wavelength at 244nm and column temperature at 35℃ RESULTS Ambroxole hydrochloride and clenbuterol hydrochloride could be - 2. 278mg · mL-1 （ r = 0. 9999） and clenbuterol hydrochloride was 0. 494 - 247μg · mL- 1 （ r = 1 ）. CONCLUSION The method is simple, accurate and is suitable for the determina- tion of ambroxole hydrochloride and clenbuterol hydrochloride.