高效液相色谱法测定复方茶新那敏片中马来酸氯苯那敏含量

目的 建立测定复方茶新那敏片中马来酸氯苯那敏含量的高效液相色谱法.方法 采用C18硅胶柱(250mm×4.6mm,5μm),流动相为0.5%三乙胺溶液(磷酸调pH至4.5)-乙腈-甲醇(275:184:41),流速为1.0 mL/min,柱温为25℃,检测波长为264 nm;理论塔板数按马来酸氯苯那敏峰计算为6 500,分离度R>1.5.结果 马来酸氯苯那敏进样量在0.002 378-0.665 840/.Lg(r=1.000)范围内与峰面积线性关系良好,平均回收率为99.05%,RSD=1.50%.结论 该方法简便、稳定,可作为茶新那敏片中马来酸氯苯那敏的含量测定方法.

Determination of Chlorphenamine Maleate in Compound Chaxinnamin Pills by HPLC

Objective To astabish the testing method of the chlorphenamine maleate in Compound Chaxinnamin Pills by HPLC.Methods The C18（250 mm×4.6 mm,5 μm） column was adopted;the mobile phase is 0.5%thiethylamine water solvent（adapt pH to 4.5 with the phosphoric acid）-acetonitrile-methanol（275 ∶184 ∶41）;the flow rate is 1 mL/min and the column temperature is 25 ℃;testing wavelength is 264 nm;the plate which calculated by chlorphenamine maleate is 6 500 and R 〉1.5 which are reach the CP standard.Results The good linear relationship for chlorphenamine maleate was in the range of 0.002 378-0.665 840 mg（r=1.000 0）,the arerage recorery rate wsa 99.05%,RSD=1.50%（n=9）.Conclusion the method is so convenient and stable that it can be used as the concentration testing method of the chorphenamine maleat in Compound Chaxinnamin Pills.