Fast and sensitive determination of Polysorbate 80 in solutions containing proteins

被引：52

作者：

Fekete, Szabolcs ^{[1
]}

Ganzler, Katalin ^{[1
]}

Fekete, Jenoe ^{[2
]}

机构：

[1] Gedeon Richter Plc, Formulat Dev, Budapest X, Hungary

[2] Budapest Univ Technol & Econ, Dept Inorgan & Analyt Chem, H-1111 Budapest, Hungary

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2010年 / 52卷 / 05期

关键词：

Fast chromatography; Shell particles; Charged aerosol detection; Detection of non-chromophoric excipient; Tween; 80; PERFORMANCE LIQUID-CHROMATOGRAPHY; RAPID ANALYSIS; SURFACTANTS; INSULIN; PEPTIDES;

D O I：

10.1016/j.jpba.2010.02.035

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A fast and sensitive method has been developed for the specific determination of Polysorbate 80 (Tween 80) in liquid formulations in the presence of proteins and excipients The quantitative determination is based on a fast liquid chromatographic (HPLC) separation and charged aerosol detection (CAD) The method was validated using a Poroshell 300SB-C18 column packed with 5 mu m shell particles (75 mm x 2 1 mm) and acetonitrile-methanol-water-trifluoroacetic acid mobile phase at a flow late of 065 ml/min The rapid LC-CAD method is suitable for quantifying Polysorbate 80 in the range of 10-60 mu g/ml in protein solutions within good manufacturing pi actices (GMPs) of the pharmaceutical industry (C) 2010 Elsevier B V All rights reserved

引用

页码：672 / 679

页数：8

共 25 条

[1] DETERMINATION OF POLYOXYETHYLENE NON-IONIC SURFACTANTS AT TRACE LEVELS [J].

ANDERSON, NH ;

GIRLING, J .

ANALYST, 1982, 107 (1276) :836-838

[2]

[Anonymous], 1994, ICH HARM TRIP GUID Q

[3] AGGREGATION OF INSULIN, CONTAINING SURFACTANTS, IN CONTACT WITH DIFFERENT MATERIALS [J].

CHAWLA, AS ;

HINBERG, I ;

BLAIS, P ;

JOHNSON, D .

DIABETES, 1985, 34 (05) :420-424

[4]

CIABB NT, 1964, J AM OIL CHEM SOC, V41, P752

[5] Development and testing of a detection method for liquid chromatography based on aerosol charging [J].

Dixon, RW ;

Peterson, DS .

ANALYTICAL CHEMISTRY, 2002, 74 (13) :2930-2937

[6]

FOISATZ B, 2007, LC GC N AM, V25, P960

[7]

Gamache PH, 2005, LC GC EUR, V18, P345

[8] A COLORIMETRIC METHOD FOR DETERMINATION OF PARTS/MILLION OF NONIONIC SURFACTANTS [J].

GREFF, RA ;

SETZKORN, EA ;

LESLIE, WD .

JOURNAL OF THE AMERICAN OIL CHEMISTS SOCIETY, 1965, 42 (03) :180-&

[9] Comparison between the efficiencies of columns packed with fully and partially porous C18-bonded silica materials [J].

Gritti, Fabrice ;

Cavazzini, Alberto ;

Marchetti, Nicola ;

Guiochon, Georges .

JOURNAL OF CHROMATOGRAPHY A, 2007, 1157 (1-2) :289-303

[10] RAPID ANALYSIS OF RIBONUCLEOSIDES AND BASES AT PICOMOLE LEVEL USING PELLICULAR CATION EXCHANGE RESIN IN NARROW BORE COLUMNS [J].

HORVATH, C ;

LIPSKY, SR .

ANALYTICAL CHEMISTRY, 1969, 41 (10) :1227-&

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