Micellar electrokinetic chromatography method development for determination of impurities in Ritonavir

被引：11

作者：

Carvalho, Alexandre Zatkovskis ^{[1
]}

El-Attug, Mohamed Nouri ^{[1
]}

Zayed, Sahar Ebrahem ^{[1
]}

Van Hove, Els ^{[1
]}

Van Duppen, Joost ^{[1
]}

Hoogmartens, Jos ^{[1
]}

Van Schepdael, Ann ^{[1
]}

机构：

[1] Katholieke Univ Leuven, Lab Pharmaceut Anal, Fac Farmaceut Wetenschappen, B-3000 Louvain, Belgium

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2010年 / 53卷 / 05期

关键词：

Capillary electrophoresis; MEKC; Quality control; Ritonavir related substances; Mass spectrometry; REVERSE-TRANSCRIPTASE INHIBITORS; IMMUNODEFICIENCY-VIRUS THERAPY; PROTEASE INHIBITORS; SIMULTANEOUS SEPARATION; HUMAN SERUM; CAPILLARY;

D O I：

10.1016/j.jpba.2010.07.022

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

Ritonavir is a synthetic peptidomimetic human immunodeficiency virus (HIV) protease inhibitor employed in the treatment of AIDS since 1996. Synthetic precursors are potential impurities in the final product. In the present work a micellar electrokinetic chromatography (MEKC) method for the separation of Ritonavir from three available synthetic precursors was developed. The optimized separation is performed in a background electrolyte composed of sodium tetraborate (pH 9.6: 15 mM) containing sodium dodecylsulfate (30 mM) and acetonitrile (18%, v/v) Mass spectrometry was used to confirm the identity of the tested substances. Good repeatability was observed for migration time (RSD about 0.4%) and peak area (RSD about 0 8%). The limits of detection (LOD) obtained allow the determination of two of the impurities at levels as low as 0.005% m/m, and one at a level of 0.3% m/m. (C) 2010 Elsevier B.V All rights reserved.

引用

页码：1210 / 1216

页数：7

共 23 条

[1] Capillary electrophoresis for the analysis of small-molecule pharmaceuticals [J].