高效液相色谱法测定氯霉素搽剂的含量

Determination of Chloramphenicol in Chloramphenicol Liniment by HPLC

目的:建立氟霉素搽剂中氯霉素的含量测定方法。方法:采用高效液相色谱法。色谱柱:Nova-Pak C_(18)柱(150×3.9mm,4um);流动相:0.05mol/L 磷酸二氢钾溶液-甲醇-乙腈(80:40:15);流速:1ml/min;检测波长:278nm;进样量:20μl。采用外标法测定含量。结果:本色谱条件下空白辅料不干扰主峰,氯霉素在0.5～5.0μg/ml 的浓度范围内,峰面积与进样量呈良好的线性关系(r=0.9999),含量测定的回收率为99.3%～100.6%,RSD 为0.58%。结论:该方法专属性强,操作方便,结果准确,重现性好。

Objective： To establish a method for the determination of Chloramphenicol in Chloramphenicol liniment by HPLC.Methods： Reversed-phase Chloramphenicol separation was carried out on a Nova-Pak C18 eohrnn（150mm×3.9mm, 4um） equilibrated with an eluent mixture constituted by 0.05mol/L potassium dihydrogen phosphate solution-Methanol- Acetonitrile（ 80： 40： 15） .The ultraviolet detection was at 278nm.The quantitative determination of Chloramphenicol was performed with external standard method and the impurity limitation was performed with area normalization method.Results： No interference frcrn liniment excipient was found under optimum conditions.The standard curve was linear over the concentration range of 0.5 to 5.0μg·ml^-1 for Chloramphenicol.The recovery of Chloramphenicol was in the range of 99.3% to 100.6% with RSD is 0.58% .Conclusion： The separation method is accurate, reproducible and highly selective.