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氟哌利多的液相色谱测定及降解研究

LC determination and degradation study of droperidol.

作者信息

Trabelsi H, Guettat S, Bouzouita K, Safta F

机构信息

Laboratoire National de Contrôle des Médicaments 11bis, rue jebel Lakhdar, Bab Saadoun, 1006 Tunis, Tunisia.

出版信息

J Pharm Biomed Anal. 2002 May 15;28(3-4):453-62. doi: 10.1016/s0731-7085(01)00597-0.

Abstract

A specific, high performance liquid chromatographic method for the determination of droperidol in the presence of its degradation products is described. The method is based on the use of an amide functionalized bonded phase column (LC-ABZ(+) Plus) and a simple mobile phase of methanol-sodium phosphate monobasic (0.05 M, pH 4.5) (40:60, v/v). It enables the resolution of eight compounds from the parent drug and from each other. The degradation was carried out in hydrochloric acid, sodium hydroxide and hydrogen peroxide. The main degradation products were identified. Application of the assay for a commercial preparation of droperidol for injection is presented.

摘要

描述了一种在存在其降解产物的情况下测定氟哌利多的特定高效液相色谱法。该方法基于使用酰胺官能化键合相柱(LC - ABZ(+) Plus)和甲醇 - 磷酸二氢钠(0.05 M,pH 4.5)(40:60,v/v)的简单流动相。它能够分离母体药物及其相互之间的八种化合物。在盐酸、氢氧化钠和过氧化氢中进行降解。鉴定出主要降解产物。介绍了该测定法在氟哌利多注射剂商业制剂中的应用。

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