小儿氨酚黄那敏颗粒中马来酸氯苯那敏含量测定及含量均匀度考察

Determination of the Content and Uniformity of Chlorphenamine Maleate in Children' s Anfen Huang Namin Granules by HPLC

目的:建立高效液相色谱法测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏的含量及含量均匀度。方法:采用C18柱(250mm×4.6mm,5μm),以甲醇-0.5mol/L磷酸二氢钠-三乙胺(150∶850∶0.25),用磷酸调节pH值至2.3为流动相,流速为1mL/min,检测波长为215nm,以外标法测定含量。结果:马来酸氯苯那敏在0.05～0.5μg的范围内线性关系良好,r=0.9998,平均回收率为96.02%,RSD为0.9%(n=5)。结论:高效液相色谱法简便、快速,重现性好。

Objective:To establish a HPLC method for the content and uniformity determination of Chlorphenamine maleate in children' s anfen huang namin granules.Methods:The C 18 column(250mm ×4.6mm,5μm)was used and the mobile phase was methanol -0.5mol /L sodium dihydrogen phosphate -triethylamine(150∶850∶0.25),adjusted pH to2.3using phosphoric acid,the flow rate was1mL /min and the wavelength of detection was215nm.The external standard method was adopted for the assay.Results:The linear was0.05～0.5μg (r=0.9998),the average recovery rate was96.02%,RSD=0.9%(n=5).Conclusion:The method is simple,quick and precise.