HPLC法同时测定复方氨酚烷胺片中咖啡因、马来酸氯苯那敏的含量及含量均匀度

目的建立用高效液相色谱法同时测定复方氨酚烷胺片中咖啡因、马来酸氯苯那敏的含量及含量均匀度。方法色谱柱为Agilent TC-C18(4.6 mm×250 mm,5μm);以乙腈-水-三乙胺(16∶84∶0.5)(用磷酸调节pH值至2.5)为流动相;流速为1.0 mL.min-1;检测波长为262 nm。结果咖啡因和马来酸氯苯那敏分别在0.596 8～2.387 2μg和0.080 1～0.320 3μg范围内与峰面积呈良好线性关系,r值分别为1.000,0.999 9。平均回收率分别为99.7%,99.5%,RSD分别为0.59%,0.68%(n=9)。结论本方法专属性好,简便、快速、准确,适用于复方氨酚烷胺片中咖啡因和马来酸氯苯那敏含量及含量均匀度的测定。

Determination of content and content uniformity of caffeine and chlorphenamine maleate in Compound Paracetamol and Amantadine Hydrochloride Tablets by HPLC

Objective To establish an HPLC method for the determination of content and content uniformity of caffeine and chlorphenamine maleate in Compound Paraeetamol and Amantadine Hydrochloride Tablets. Method The analytical column was Agilent TC - C18 （4.6 mm× 250 mm,5 μm）. The mobile phase was acetonitrile - water - triethylaminnm （ 16： 84：0.5 ） （ adjusted the pH to 2.5 with phosphate acid）. The flow rate was 1.0 mL.min^ - 1 and the detection wavelength was 262 nm. Results The linear ranges of caffeine and ehlorphenamine maleate were 0. 596 8 - 2. 387 2 μg and 0. 080 1 - 0. 320 3 μg with relative coefficient r = 1. 000, r = 0. 999 9, respectively. The average recoveries were 99.7 % and 9.5 % with the RSD of 0.59 % and 0.68 % （ n = 9 ） , respectively. Conclusion The method was specific, simple, rapid and accurate, and it was suitable for the determination of content and content uniformity of caffeine and chlorphenamine maleate in Compound Paracetamol and Amantadine Hydrochloride Tablets.