Assessment of MEKC suitability for residue drug monitoring on pharmaceutical manufacturing equipment

被引：8

作者：

Boca, Madalina Brindusa ^{[2
]}

Pretorius, Etheresia ^{[2
]}

Kgaje, Christopher ^{[3
]}

Apostolides, Zeno ^{[1
]}

机构：

[1] Univ Pretoria, Fac Nat & Agr Sci, Dept Biochem, ZA-0002 Pretoria, South Africa

[2] Univ Pretoria, Fac Hlth Sci, Dept Anat, ZA-0002 Pretoria, South Africa

[3] CSIR, BIO Chemtek, ZA-1645 Johannesburg, South Africa

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2008年 / 46卷 / 04期

关键词：

MEKC; cleaning validation; co-trimoxazole; antibacterial drug; sulfamethoxazole; trimethoprim; sulfanilic acid; sulfanilamide; 3,4,5-trimethoxybenzoic acid; nonoxynol-9;

D O I：

10.1016/j.jpba.2007.11.022

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The suitability of micellar electrokinetic chromatography for the simultaneous trace determination of several compounds (sulfamethoxazole, trimethoprim, sulfanilic acid, sulfanilamide, 3,4,5-trimethoxybenzoic acid and nonoxynol-9) was assessed. The mixture was separated within 14 min at an applied voltage of 22 kV by using 30 mM phosphate electrolyte, containing 10 mM SDS, adjusted to pH 7.8. Under optimized separation conditions acceptable levels of linearity, precision and accuracy were obtained for all compounds. The method could be used as part of a cleaning validation study when assaying trace levels of co-trimoxazole drug, some of its decomposition products and detergent in the swab samples collected from pharmaceutical manufacturing equipment, after cleaning. (C) 2007 Elsevier B.V. All rights reserved.

引用

页码：631 / 638

页数：8

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