反相高效液相色潽法检测复方二氧丙嗪茶碱片中盐酸克伦特罗含量及含量均匀度

Determination of Content and the Content Uniformity of Clenbuterol Hydrochloride in Compound Dioxopromethazine Hydrochloride Tablets by RP-HPLC

目的:建立高效液相色谱法检测复方二氧丙嗪茶碱片中盐酸克伦特罗含量及含量均匀度。方法:色谱柱为Agilent-C18(150mm×4.6mm,5μm);流动相为乙腈-甲醇-水-三乙胺(250:125:625:1)(用磷酸调节pH值至3.0);流速为1.0m·lmin-1;检测波长:243nm。结果:盐酸克伦特罗在2.134～26.68μg·ml-1范围内,与峰面积值呈良好的线性关系,r=0.9997;平均加样回收率为99.27%,RSD=1.17(n=9)。结论:方法简便、准确、重复性好。

Objective：To establish a method for the determination of content and content uniformity of Clenbuterol Hydrochloride in compound dioxopromethazine hydrochloride tablets by RP-HPLC. Method： The column was Agilent-C 18 （150mm×4.6mm, 5 μ m）; The mobile phase was acetonitrile-methanol-water-triethylamine （250：125：625：1）,PH was adjusted 3.0 with phosphoric acid; The flow rate was 1.0ml·min^-1 with detection wavelength at 243nm. Result： The linear range of Clenbuterol Hydrochloride was 2.134 - 26.68 μ g· ml^-1 ,r=-0.9997; The average recovery was 99.27% and RSD=1.17（n=9）. Conclusion： The method is simple, accurate and suitable.