HPLC法测定酚氨咖敏片中咖啡因与马来酸氯苯那敏的含量均匀度

目的：建立测定酚氨咖敏片中咖啡因与马来酸氯苯那敏的含量均匀度的方法。方法：采用Shiseido Capcell Pak C 18色谱柱（4.6 mm ×250 mm，5μm），以1％醋酸溶液（用二乙胺调节pH值至3.7）-甲醇（68∶32）为流动相，流量1.0 mL· min-1，检测波长272 nm（咖啡因）/260 nm（马来酸氯苯那敏）。结果：咖啡因在0.2474～0.7421μg范围内线性关系良好（ r＝1.000），平均回收率为99.26％，RSD为0.84％；马来酸氯苯那敏在0.2192～0.6574μg范围内线性关系良好（ r＝1.000），平均回收率为103.72％，RSD为0.53％。结论：该方法准确可靠，能更好地控制产品内在质量。

Determinations of Content Uniformity of Caffeine and Chlorphenamine Maleate in Paracetamol, Aminophenazone Caffeine and Chlorphenamine Maleate Tablets by HPLC

Objective：To establish an HPLC method for determinations of content uniformity of caffeine and chlorphenamine maleate in Paracetamol , Aminophenazone Caffeine and Chlorphenamine Maleate Tablets.Methods：The analysis was carried out on a Shiseido Capcell Pak C18 column（4.6 mm ×250 mm,5 μm）with mobile phase of 1% acetate buffer（adjusted to pH 3.7 with diethylamine）-methol（68∶32）at a flow rate of 1 mL· min-1.The detective wavelength was set at 272 nm to detect caffeine and 260 nm to detect chlorphenamine maleate.Results：The calibration curve of caffeine was linear in the range of 0.2474-0.7421 μg（ r=1.000 ） ,the av-erage recovery was 99.26%with RSD 0.84%;the calibration curves of chlorphenamine maleate was linear in the range of 0.2192-0.6574 μg（ r=1.000 ） ,the average recovery was 103.72%with RSD 0.53%.Conclusion：The method is reliable ,accurate and can be applied to the quality control of the preparation.