HPLC法同时测定鼻炎康片中马来酸氯苯那敏、盐酸麻黄碱和盐酸伪麻黄碱

摘要

Objective To establish a method for determination of chlorphenamine maleate,ephedrine hydrochloride and pseudoephedrine hydrochloride in Biyankang tablets by high performance liquid chromatography (HPLC),providing the method of quality control.Methods Phenomenex C18 column (250 mm × 4.6 mm,5 μm) is used for the HPLC analysis.The mobile phase consisted of acetonitrile-0.5％ sodium dodecyl silfonate-phosphoric acid (58:42:0.1) and eluted at the flow rate of 1 ml/min.The column temperature is maintained at 35℃.The detection wavelength is set at 264 nm (chlorphenamine maleate) and 210 nm (ephedrine hydrochloride and pseudoephedrine hydrochloride).The injection volume is 10 μl.Results The three compounds have good linear relationship (r =0.999 2) in wide concentration (3.03 ～ 102.5 μg/ml).The average recovery rates (n =3) are 97.4％ ～ 99.8％,and the RSD below 1.53％.Conclusion This method has high sensitive,high accuracy and good repeatability,which can be used to control the quality of Biyankang tablets.%目的 建立高效液相色谱法(HPLC)同时测定鼻炎康片中马来酸氯苯那敏、盐酸麻黄碱和盐酸伪麻黄碱的含量,为该药提供质量控制方法.方法 采用Phenomenex C18色谱柱(250 rmn×4.6 mm,5μm),流动相为乙腈-0.5％十二烷基磺酸钠-磷酸(58:42:0.1),流速1.0 ml/min,柱温35℃,检测波长264 nm(马来酸氯苯那敏)和210 nm(盐酸麻黄碱、盐酸伪麻黄碱),进样量10 μ1.结果 3种成分在宽浓度范围内(3.03 ～ 102.5 μg/ml)呈良好的线性关系(r＞0.999 2),平均加样回收率(n=3)为97.4％～99.8％,且RSD小于1.53％.结论 该方法灵敏度高、准确度高、重复性好,可用于控制鼻炎康片的质量.