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

Determination of Chlorphenamine Maleate in Compound Chaxinnamin Pills by HPLC

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(250 mm×4.6 mm,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 840μg(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。

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.