高效液相色谱法测定针剂中双氯灭痛含量

Determination of Diclofenac Sodium in Injection by High Performance Liquid Chromatography (HPLC)

双氯灭痛是非甾体抗炎、解热镇痛药,对类风湿关节炎、骨关节炎等引起的疼痛有较好疗效,已应用于临床。国内仍采用容量法测定,近年来国外已有报道用高效液相色谱法测定双氯灭痛。本文介绍用高效液相色谱法(HPLC)测定针剂中双氯灭痛含量,结果表明,用7μm的ODS固定相,甲醇-水(70∶30,V/V)作流动相,用内标法可在5分钟内完成双氯灭痛和内标物对硝基苯甲酸的良好分离,方法较有关文献报道简便快速,具有较好的精密度和准确度。

This paper describes an HPLC procedure for the assay of diclofenac sodium in injection. The assay was carried out on a 200 mm×5 mm column with 7nm ODS using methanol and water (70 : 30) as mobile phase, with UV detection at 277 nm. The elution was performed at the flow rate of 1 ml/min. This method is simple, accurate and rapid.