高效液相色谱法测定人血浆中复方氨酚帕马溴的含量

Determination of two constituents in compound acetaminophen and pamabrom tablets in human plasma by high performance liquid chromatography

目的:建立快速测定人血浆中复方氨酚帕马溴含量的高效液相色谱法。方法:在盐酸酸性条件下用乙酸乙酯对血样进行提取,采用Diamonsil ^(TM)C_(18)柱,以茶碱为内标,同时测定血浆中对乙酰氨基酚和帕马溴的浓度。流动相:0．2％三氟乙酸水溶液:乙腈=87:13(V/V);检测波长:0．00～8．00 min为249 nm,8．01～13．00 min为278 nm。结果:对乙酰氨基酚和帕马溴的保留时间分别为5．9 min和11．3 min, 2药的线性范围都是0．02～20 mg·L^(-1),提取回收率大于60％(n=5),方法回收率大于90％(n=5),日内、日间RSD小于7．5％(n=5)。结论:本试验方法简便快速、灵敏准确,适用于复方氨酚帕马溴制剂药动学、生物等效性研究。

AIM： To establish a in compound acetaminophen and from plasma with ethyl acetate in pamab rapid HPLC method rom tablets in human for determination of acetaminophen and pamabrom plasma. METHODS： The samples were extracted hydrochloric acid surroundings. Chromatograph was carried out on a Diamon-sil^TM C18 column, using theophylline as internal standard, and the concentrations of acetaminophen and pamabrom were determined simultaneously. The mobile phase was 0.2 % trifluoroacetic acid-acetonitrile （87 ： 13, V/V）, the detection wavelength was set as follows： 0.00 - 8.00 min： 249 nm, 8.01 - 13.00 min： 278 nm. RE- SULTS： The retention time of acetaminophen and pamabrom were approximately 5.9 min and 11.3 min, respectively. A good linearity was shown in the concentration range 0.02 - 20 mg·L^-1 for both constituents. The extraction recovery was more than 60 % （n = 5） and the method recovery was more than 70 % （n = 5）. The interday or intraday precision was less than 7.5 % in replicate analysis （n = 5）. CONCLUSION： This HPLC method is simple, quick, sensitive and accurate. It is suitable for clinical pharmacokinetic or bioequivalence study of compound acetaminophen and pamabrom tablets.