Analysis of polymyxin B sulfate by capillary zone electrophoresis with cyclodextrin as additive Method development and validation

被引:31
作者
Kang, JW [1 ]
Van Schepdael, A [1 ]
Orwa, JA [1 ]
Roets, E [1 ]
Hoogmartens, J [1 ]
机构
[1] Katholieke Univ Leuven, Fac Farmaceut Wetenschappen, Lab Farmaceut Chem & Analyse Geneesmiddelen, B-3000 Louvain, Belgium
关键词
validation; pharmaceutical analysis; polymyxin B sulfate; antibiotics; cyclodextrins;
D O I
10.1016/S0021-9673(00)00343-5
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A capillary zone electrophoresis method for analysis of polymyxin B sulfate is described. In this method, triethanolamine (TEA)-phosphate buffer at pH 2.5 was employed to reduce the adsorption of analyte onto the capillary wall. Methyl-beta-cyclodextrin (M-beta-CD) and 2-propanol (IPA) were found to be necessary for selectivity enhancement. In order to optimize the method and to control its robustness, a central composite design was performed with four parameters, i.e. concentration of M-beta-CD, TEA, IPA and buffer pH. The optimal separation conditions were as follows: capillary, 55 cm (50 mu m I.D., 47 cm effective length); 130 mM TEA-phosphate buffer (pH 2.5) containing 5 mM M-beta-CD and 5% IPA; 24 kV (51 mu A) applied voltage; column temperature, 20 degrees C. Further, linearity and limits of detection quantification were examined. Three commercial samples were analyzed quantitatively. (C) 2000 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:211 / 218
页数:8
相关论文
共 34 条
[1]   Liquid chromatographic analysis of a formulation containing polymyxin, gramicidin and neomycin [J].
Adams, E ;
Schepers, R ;
Gathu, LW ;
Kibaya, R ;
Roets, E ;
Hoogmartens, J .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1997, 15 (04) :505-511
[2]   THE APPLICATION OF EXPERIMENTAL-DESIGN TO THE ROBUSTNESS TESTING OF A METHOD FOR THE DETERMINATION OF DRUG-RELATED IMPURITIES BY CAPILLARY ELECTROPHORESIS [J].
ALTRIA, KD ;
FILBEY, SD .
CHROMATOGRAPHIA, 1994, 39 (5-6) :306-310
[3]  
ALTRIA KD, 1996, J CHROMATOGR A, V735, P53
[4]  
BARNARD J H, 1984, Analytical Proceedings, V21, P238
[5]   Comparison of aqueous and non-aqueous capillary electrophoresis for quantitative determination of morphine in pharmaceuticals [J].
Bjornsdottir, I ;
Hansen, SH .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1997, 15 (08) :1083-1089
[6]   EXPERIMENTAL-DESIGN ON LIQUID-CHROMATOGRAPHIC PARAMETERS IN THE ANALYSIS OF TETRACYCLINE ON POLY(STYRENE DIVINYLBENZENE) [J].
DEBEER, JO ;
HOOGMARTENS, J .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1993, 11 (11-12) :1239-1250
[7]   ISOLATION AND CHARACTERIZATION OF 3 NEW POLYMYXINS IN POLYMYXIN-B AND POLYMYXIN-E BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
ELVERDAM, I ;
LARSEN, P ;
LUND, E .
JOURNAL OF CHROMATOGRAPHY, 1981, 218 (1-3) :653-661
[8]   Experimental design methodologies to optimize the CE separation of epinephrine enantiomers [J].
Fanali, S ;
Furlanetto, S ;
Aturki, Z ;
Pinzauti, S .
CHROMATOGRAPHIA, 1998, 48 (5-6) :395-401
[9]   SEPARATION OF OPTICAL ISOMERS BY CAPILLARY ZONE ELECTROPHORESIS BASED ON HOST GUEST COMPLEXATION WITH CYCLODEXTRINS [J].
FANALI, S .
JOURNAL OF CHROMATOGRAPHY, 1989, 474 (02) :441-446
[10]   IMPROVED HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY OF CYCLIC POLYPEPTIDE ANTIBIOTICS - POLYMYXIN-B - ITS APPLICATION TO ASSAYS OF PHARMACEUTICAL FORMULATIONS [J].
FONG, GWK ;
KHO, BT .
JOURNAL OF LIQUID CHROMATOGRAPHY, 1979, 2 (07) :957-968