愈酚茶碱那敏片质量标准的改进研究

目的改进愈酚茶碱那敏片质量标准,建立HPLC测定愈酚茶碱那敏片中茶碱、愈创甘油醚和马来酸氯苯那敏含量的方法。方法采用Insteril C8-3色谱柱（250mm×4.6mm,5μm）,流动相：0.5%磷酸溶液（0.5%三乙胺,氨水调pH至5.5）-甲醇（55∶45）,柱温：30℃,检测波长：223nm,流速：1.0mL·min-1。结果茶碱、愈创甘油醚、马来酸氯苯那敏分别在0.097 5～1.560 0μg（r=0.999 8）、0.053 8～0.860 8μg（r=1.000 0）、0.050 9～0.815 1μg（r=0.999 9）范围内线性关系良好,平均回收率分别为99.31%、99.39%、99.27%,RSD分别为0.55%、0.68%、0.44%（n=9）。结论经方法学验证,所建立方法可用于愈酚茶碱那敏片中愈创甘油醚、茶碱和马来酸氯苯那敏的含量测定,为现行标准改进提供参考。

Study on the Improvement of Standard of Guaiacol Theophylline and Chlorpheniramine Maleate Tablets

Objective To improve the standard of Guaiacol Theophylline and Chlorpheniramine Maleate Tablets and to establish an HPLC method for the assay of theophylline,guaifenesin and chlorpheniramine maleate in Guaiacol Theophylline and Chlorpheniramine Maleate Tablets.Methods The procedure was performed on the Insteril C8-3column（250 mm×4.6 mm,5μm）at 30 ℃,detected at223 nm.The mobile phase was composed of 0.5% phosphate solution（in which 0.5% of triethylamine was added and the pH was adjusted to 5.5by ammonia）and methanol（55∶45）,fluxed at a rate of1.0mL·min-1.Results Theophylline,guaifenesin and chlorpheniramine maleate were in good linear in the range of 0.097 5-1.560 0μg（r=0.999 8）,0.053 8-0.860 8μg（r=1.000 0）,0.050 9-0.815 1μg（r=0.999 9）,respectively.The mean recoveries were 99.31%,99.39%,99.27% with the RSD 0.55%,0.68% and 0.44%（n =9）.Conclusion The method is proved to be simple,rapid and accurate,appropriate for the assay of theophylline,guaifenesin and chlorpheniramine maleate in Guaiacol Theophylline and Chlorpheniramine Maleate Tablets,and it can provide a reference for the improvement of current standard.