HPLC法测定咳特灵胶囊(片)中马来酸氯苯那敏的含量

Determination of chlorphenamine maleate in Keteling capsules (tablets) by HPLC

目的 为了控制咳特灵胶囊 (片 )的质量 ,建立马来酸氯苯那敏的含量测定方法。方法 HPLC测定马来酸氯苯那敏的含量 ,用KromasilC18柱 ,流动相为乙腈 3 %冰乙酸 三乙胺 (2 0∶ 80∶ 0 .0 8) ,醋酸调节pH =3 .0 ;检测波长 2 62nm ;流速 1.5ml/min。结果 马来酸氯苯那敏在 81～ 40 8μg范围内线性关系良好 (r =0 .9999) ,平均回收率为 98.1%。RSD =0 .67%。 结论 本法方便、快速、准确、可作为咳特灵胶囊 (片 )

Objective To control the quality of Keteling capsules (tablets),establish the determinati on of chlorphenamine maleate. Methods HPLC was used to determin e the content of chlorphenamine maleate on C 18 column with a mobile phase of acetonitrile -3% acetic acid-triethylamine (20∶70∶0.08); pH was adjusted to 3.0 by acetic acid;UV detection wavelength at 262 nm;flow r ate:1.5 ml/min;Results Chlorphenamine maleate showed a good l inerity at a range of 81～408μg, r=0.9999;The average recoovery was 98.1% a nd RSD was 0.67%.(n=5). Conclusion This method is convenien t, accurate and available for the quality control of Keteling capsules (tablets) .