高效液相色谱法测定咳特灵分散片中马来酸氯苯那敏的含量

Determination of Chlorphenamine Maleate in Keteling Dispersible Tablet by HPLC

目的建立咳特灵分散片中马来酸氯苯那敏的含量测定方法。方法采用HPLC法测定马来酸氯苯那敏的含量,色谱柱为Nucleodur C18 Gravity（250 mm×4.6 mm,5μm）;流动相为乙腈-水溶液（含0.3%冰乙酸、0.1%三乙胺）（27∶73）;流速1.0 ml/min;检测波长262 nm。结果马来酸氯苯那敏在0.0302-0.906μg范围内呈良好线性关系,r=0.9999;平均回收率为99.5%,RSD=1.5%。结论该方法可准确地进行咳特灵分散片定量检测,可用于该制剂的质量控制。

Objective To establish a method for the determination of ehlorphenamine maleate in Keteling Dispersible Tablet by HPLC. Methods HPLC was performed on Nueleodur C,s Gravity（250 mm×4.6 mm ,5μm）. The mobile phase was aeetonitril - water （0.3% acetic acid, 0.1% triethylamine） （27：73 ）. The detection wavelength was 262 nm and flow rate was 1.0 ml/min. Results Chlorphenamine maleate showed a good linearity in the range of 0.0302 - 0.906μg, r = 0. 9999. The average reeovery was 99.5% ,and RSD was 1.5%. Conclusion This method is effeetive and ean be used for the quality eontrol of ehlorphenamine maleate in Keteling Dispersible Tablet.