RP-HPLC法测定马来酸氯苯那敏片中马来酸氯苯那敏的含量

目的建立以反相高效液相色谱法测定马来酸氯苯那敏片中马来酸氯苯那敏含量的方法。方法色谱柱为Agilnet TC-C18（150mm×4.6mm,5μm）,流动相为0.005mol/L辛烷磺酸钠（用醋酸调节pH3.0）∶乙腈=3∶1,流速为1.0ml/min,柱温为30℃,检测波长为260nm。结果马来酸氯苯那敏浓度在0.005～0.05mg/ml范围内与峰面积积分值呈良好线性关系（r=0.9995）;平均回收率为99.0%,RSD=0.8%（n=9）。结论本方法操作简便,测定结果准确、重现性好,可用于测定马来酸氯苯那敏片中马来酸氯苯那敏的含量。

RP-HPLC method for the determination of chlorphenamine maleate in chlorphenamine maleate tablet

Objective To establish a method for the determination of chlorphenamine maleate in chlorphenamine maleate tablet by RP-HPLC.Methods Chromatography was performed on Agilnet TC-C18（150mm×4.6mm,5μm）,the mobile phase was 0.005mol/L octanesulfonic acid sodium salt solution-Acetonitrile（3∶1）（adjust pH 3.0 with acetate）,the flow rate was 1.0ml/min and detective wavelength was 260nm.Results Chlorpheniramine maleate concentration in the range of 0.005～0.05mg/ml integral value within the peak area showed good linear relationship（r=0.9995）;The average recovery was 99.0% and RSD was 0.8%.Conclusion This method is easy to operate and has good accuracy and repeatability.It can be used for the quality control of chlorphenamine maleate tablet.