HPLC法测小儿氨酚黄那敏颗粒含量及含量均匀度

Content and Content Uniformity Determination of Chlorphenamine Maleate in Xiao Er An Fen Huang Na Min granule by HPLC

建立了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测定方法。采用HPLC,以Phenom enex Luna C18为色谱柱,乙腈：0.3%十二烷基硫酸钠溶液：磷酸（60：40：0.02）（用三乙胺调节pH值至3.3±0.1）为流动相;检测波长为224nm。测得马来酸氯苯那敏在0.02019~2.0190μg（R=0.9999）范围内呈线性关系,平均回收率为98.1%（RSD=1.2%）。测定方法简便,准确,可用于该制剂的质量控制。

An HPLC method for determination of chlorphenamine maleate in Xiao Er An Fen Huang Na Min granule was established,which was selected to determine the content.The analysis column was Phenomenex Luna C18.The mobile phase was acetonitrile-0.3% SDS solution-phosphoric acid（60：40：0.02）（adjust pH to 3.3±0.1 with triethylamine）.The detection wavelength was 224nm.The calibration curve was liner in the range of chlorphenamine maleate from 0.02019 to 2.0190μg（r=0.9999）.The average recovery was 98.1%（RSD=1.2%）.The method was simple and accurate and suitable for the quality control of this preparation.