高效液相色谱法测定盐酸氯胺酮注射液的含量

Determination of Clomipramine hydrochloride Injection by HPLC

目的 采用HPLC法测定盐酸氯胺酮注射液的含量。方法 采用AgilentODS色谱柱 ,4 6mm× 2 5 0mm ,5 μm ,流动相 :四氢呋喃 -水 -三乙胺 (5∶95∶0 2 )磷酸调节 pH值 3 5 ,检测波长 :2 6 9nm ,流速为 1 0ml·min-1。结果 加样回收率为99 6 % (RSD为 0 8% ,n =9) ;盐酸氯胺酮在 0 4 0 4mg·ml-1～ 1 6 16mg·ml-1范围内浓度与面积呈良好的线性关系。结论 本法测定盐酸氯胺酮注射液的含量 ,结果准确 。

Objective To determine and control quality of Clomipramine hydrochloride Injection by HPLC.Methods Clomipramine hydrochloride was separated by C_(18) column with tetrahydrofuran-water-triethylamine(5∶95∶0.2),adjusted by phosphoric acid to pH?3.5 as mobile phase.Determination wave-length was 269nm. Flow speed was 1ml·min^(-1).Results The recovery of added sample was 99.6%,and RSD was 0.8%(n=9).There was a good linear relationship between the concentration of Clomipramine hydrochloride and absorption area value in the range of 0.404mg·ml^(-1)～1.616mg·ml^(-1).Conlusion This method was highly reproducible and accurate for the determination of Clomipramine hydrochloride in Clomipramine hydrochloride Injection.