液相法测定酚氨咖敏颗粒中马来酸氯苯那敏含量均匀度

Determination Uniformity of Chlorphenamine in Paracetamol Aminophenazone Phenacetin Caffeine and Chlorphenamine Maleate Granules by HPLC

目的：采用高效液相色谱法测定酚氨咖敏颗粒中马来酸氯苯那敏的含量均匀度。方法：采用十八烷基硅烷键合硅胶色谱柱，检测波长为224nm，流动相为乙腈0．3％十二烷基硫酸钠溶液一磷酸（60：40±0．02）（用三乙胺调pH值至3．3±0．1），流速为1．0mL／min，进样量为20ML，以外标法测定样品含量。结果：马来酸氯苯那敏在浓度5～100μg／mL范围内与峰面积线性关系良好，平均回收率为100．37％，RSD为0．53％。结论：该方法科学，重复性好，可用于酚氨咖敏颗粒中马来酸氯苯那敏含量均匀度的测定。

Objective：To establish a method using HPLC for determination uniformity of Chlorphenamine in Paraeetamol Amino phenazone Phenacetin Caffeine and Chlorphenamine Maleate Granules. Methods： The C18 column was used and the mobile phase was 0.3%SDS phosphoric acid（60 ： 40 ： 0.02 ）solution with pH（3. 3±0.10. The flow rate was 1.0mL . min^-1. The sampie volume was set as 20μL. Results：The linear range was 5-100g/mL,the average recovery of was 100.37 %with RSD 0.53G. Conclusion ： This method is efficient, accurate and suitable for determination uniformity of Chlorphenamine in Paracetamol Aminophenazone Phenacetin Caffeine and Chlorphenamine Maleate Granules.