HPLC法测定氨咖黄敏胶囊及其片中对乙酰氨基酚和咖啡因的含量

HPLC determination of paracetamol and caffein in paracetamol,caffein,atificial cow-bezoar and chlorphenamine maleate capsules and Tablets

目的:建立同时测定氨咖黄敏胶囊(片)中对乙酰氨基酚和咖啡因含量的 HPLC 法。方法:采用 Hypersil C_(18)(4.6 mm×150 mm,5μm)色谱柱(大连依利特),流动相为1%醋酸溶液(用二乙胺调节 pH 值至3.7)-甲醇(62:38),流速为0.8 mL·min^(-1),检测波长为272 nm,柱温为室温。结果:对乙酰氨基酚在50.0～500.0μg·mL^(-1)范围内具有良好的线性关系,r=0.9996,方法的同收率为99.5%～100.1%,RSD 为0.26%～0.30%(n=3);咖啡因在3.0～30.0μg·mL^(-1)范围内具有良好的线性关系,r=0.9997,方法的回收率为99.4%～99.7%,为0.45%～0.60%(n=3)。结论:本法简便、准确、灵敏度高,重现性好,可用于氨咖黄敏胶囊(片)中对乙酰氨基酚和咖啡因的含量测定。

Objective：To establish a method for determination of paracetamol and caffein in paracetamol, caffein, atificial cow- bezoar and chlorphenamine maleate capsules （5ablets） by HPLC. Method：The HPLC system consisted of Elite Hypersil C18 column （5 μm,4. 6 mm × 150 mm）, 0. 1% HAc （ adjust pH to 3.7 by triethylamine） - CH3OH （62：38 ） mixture as a mobile phase, detection wavelength at 272 nm,0. 8 mL ·min^-1 of flow rate and col- umn temperature at （ 25 ＋ 2 ） ℃. Result： The linear range of paracetamol was 50. 0 - 500. 0μg·mL^-1, r = 0. 9996, the method recoveries were 99.5% - 100. 1% , and the relative standard deviations were 0. 26% -0. 30% （n =3 ） ;The linear range of caffein was3.0 -30. 0 μg·mL^-1 ,r =0. 9997 ,the method recoveries were 99.4% - 99.7% , and the relative standard deviations were 0. 45 % - 0. 60% （ n = 3 ） . Conclusion： The method is simple, the result is accurate, higher sensitivity and the reproducibility is good. This method can be used for the determination of paracetamol and caffein in paracetamol, caffein, atificial cow -bezoar and chlorphenamine maleate capsules （tablets）.