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目的:建立咳特灵片及胶囊中马来酸氯苯那敏含量及含量均匀度测定方法。方法:采用HPLC法,以Spherisorb硅胶柱(150mm×5mm,5μm)为固定相,乙腈-水-冰醋酸-三乙胺(250∶250∶1.5∶0.17)为流动相,检测波长为261nm。结果:马来酸氯苯那敏在4.180~62.70μg·ml-1(r=0.9999)范围内呈良好线性关系,平均回收率为99.4%,RSD为0.5%(n=5)。结论:本方法简便准确,重复性好,可用于控制其内在质量。
Objective: To establish a method for the determination of content and evenness of chlorphenamine maleate in cough tractor tablets and capsules. Methods: The mobile phase consisted of acetonitrile-water-glacial acetic acid-triethylamine (250: 250: 1.5: 0.17) with a Spherisorb silica column (150mm × 5mm, 5μm) as the stationary phase and the detection wavelength was 261nm. Results: Chlorphenamine maleate showed a good linearity in the range of 4.180 ~ 62.70μg · ml-1 (r = 0.9999) with an average recovery of 99.4% and a RSD of 0.5% (n = 5). Conclusion: The method is simple and accurate, reproducible, and can be used to control its intrinsic quality.