高效液相色谱法同时测定氨咖黄敏胶囊中对乙酰氨基酚和马来酸氯苯那敏的含量

Content determination of paracetamol and chlorphenamine maleate in Paracetamol, Caffein, Atificial Cow-bezoar and Chlorphenamine Maleate Capsules by HPLC

目的:建立高效液相法同时测定氨咖黄敏胶囊中对乙酰氨基酚和马来酸氯苯那敏含量的方法。方法:采用Shim-Paok CLC ODS C18(6.0 mm×200 mm,5μm)色谱柱;流动相:甲醇-0.05 mol/L磷酸二氢钾溶液-三乙胺(10∶90∶0.02)(用磷酸调节pH至3.4);检测波长:215 nm;流速:1.0 ml/min;柱温:30℃。结果:对乙酰氨基酚在0.092～4.604μg范围内与峰面积呈良好的线性关系(r=0.999 8),平均回收率为98.40%,RSD=1.53%(n=6);马来酸氯苯那敏在4.160～20.800μg范围内与峰面积呈良好的线性关系(r=0.999 7),平均回收率为99.24%,RSD=1.26%(n=6)。结论:本方法简便、准确、重现性好,可用于氨咖黄敏胶囊的质量控制。

Objective： To establish a method for the content determination of paracetamol and chlorphenamine maleate in Paracetamol, Caffein, Atificial Cow-bezoar and Chlorphenamine Maleate Capsules by HPLC. Methods： The Shim-Paok CLC ODS C18 （6.0 mm×200 mm, 5 μm） column was used. The mobile phases consisted of methanol, 0.05 mol/L phosphoric acid and triethylamine solution （10：90：0.02） （adjusted pH to 3.4）, the flow rate was 1.0 ml/min and the detection wavelength was at 215 nm. The column temperature was 30℃. Results： The linear ranges of paracetamol was at 0.092-4.604 μg （r=0.999 8）, the average recoveries was 98.40% with a RSD of 1.53%（n=6）; the linear ranges of chlorphenamine maleate was at 4.160-20.800μg （r=-0.999 7）, the average recoveries was 99.24% with a RSD of 1.26% （n=6）. Conclusion： The method is fast, reliable, accurate and can be used in the quality control of paracetamol and chlorphenamine maleate in Paracetamol, Caffein, Atificial Cow-bezoar and Chlorphenamine Maleate Capsules.