HPLC法测定消炎止敏丸中马来酸氯苯那敏的含量

Determination of Chlorphenamine Maleatein in Xiaoyan Zhimin Pills by HPLC

目的:建立HPLC法测定消炎止敏丸中马来酸氯苯那敏中的含量。方法:色谱柱:Phenomenex C_(18) Gemini(250 mm×4.6mm,5μm),流动相:甲醇-0.5%磷酸溶液(65:35),柱温:室温,流速:1.0ml·min^(-1),检测波长:225nm。结果:马来酸氯苯那敏进样量0.206～1.030μg范围内与峰面积呈良好线性关系(r=0.999 6),平均回收率为99.80%,RSD=1.1%(n=5)。结论:方法简便,结果准确,可作为本品质量控制的有效方法。

Objective： To establish an HPLC method for determination of chlorphenamine maleatein in Xiaoyan Zhimin Pills. Method： The determination was performed on Phenomenex C ls column （250 mm × 4.6ram, 5 μm）with the mobile phase consisted of methanol -0.5% phosphoric acid solution （65：35 ） at ambient temperature. The flow rate was 1.0ml·min^-1. The detection wavelength was set at 225nm. Result： The good linear relationship within the range of Chlorphenamine Maleatein was O. 206 - 1. 030μg （ r = 0. 999 6, n = 5 ）. The average recovery rate was99.80% with RSD = 1.1% （n = 5 ）. Conclusion： The methods is simple and accurate and could be used for quality control of Xiaoyan Zhimin Pills.