高效液相色谱法测定氯芬黄敏片中胆红素含量  

Determination of Bilirubin in Diclofenac Sodium Chlorphenamine Maleate Tablets by HPLC

作　　者：吴琳 陈国章 

机构地区：[1]湖南省衡阳市药品检验所,湖南衡阳421001

出　　处：《中国药业》2009年第10期48-49,共2页China Pharmaceuticals

摘　　要：目的用高效液相色谱(HPLC)法测定氯芬黄敏片中胆红素含量。方法采用Eurospher-100 C18色谱柱(250mm×4mm,5μm),以甲醇-氯仿-1%磷酸溶液(81∶13∶6)为流动相,流速为1.0mL/min,检测波长为453nm,柱温为30℃。结果胆红素进样量在40～80μg(r=0.9999)范围内与峰面积线性关系良好,平均加样回收率为99.2%,RSD=0.6%(n=6)。结论HPLC法简便、准确、专属性强、重现性好,可作为氯芬黄敏片的质量控制方法。Objective To establish HPLC method for the determination of bilirubin in Diclofenac Sodium Chlorphenamine Maleate Tablests. Methods The Eurospher- 100C18 column（250 mm ×4 mm, 5 μm） was used. The mobile phase was methanol -chloroform- 1% phosphoric acid solution （81 ： 13 ： 6）. The flow rate was 1.0 mL/min. The detective wavelength was 453 nm. The column temperature was 30℃. Results The linear range of bilirubin was 40 - 80 μg（ r =0. 999 9）. The average recovery rate was 99.2%, RSD =0.6% （ n =9）. Conclusion The method is convenient and accurate with good reproducibility and specilization. It can be used for the quality control of Diclofenac Sodium Chlorphenamine Maleate Tablests Tablets.

关 键 词：胆红素 高效液相色谱法 氯芬黄敏片 含量测定 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]