Analysis of cefadroxil by micellar electrokinetic capillary chromatography: Development and validation

A method is developed and validated for analysis of the antibiotic cefadroxil using micellar electrokinetic capillary chromatography. It permits cefadroxil to be completely separated from ten of its known related substances within 15 min (including the washing procedure). The separation is performed in an acetate buffer (50 mM, pH 5.25) containing sodium dodecyl sulfate (SDS; 110 mM). The fused‐silica capillary was 44 cm long (36 cm effective length), 50 μm ID; the voltage, 18 kV; temperature, 15°C; and the detection wavelength; 254 nm. The influence of the type of buffer, buffer pH and concentration, and of the SDS concentration was investigated. The robustness of the method was examined by means of a full‐fraction factorial design. The parameters for validation such as linearity, precision, limit of detection and limit of quantitation are also reported.

[1]  H. Fabre,et al.  Evaluation of capillary zone electrophoresis and micellar electrokinetic capillary chromatography with direct injection of plasma for the determination of cefotaxime and its metabolite. , 1997, Analytical chemistry.

[2]  R. Neubert,et al.  Application of capillary zone electrophoresis in cephalosporin analysis. , 1997, Journal of chromatography. B, Biomedical sciences and applications.

[3]  Shou‐Mei Wu,et al.  Micellar Electrokinetic Chromatography of Cephalosporin Antibiotics , 1996 .

[4]  S. Terabe,et al.  Micellar electrokinetic chromatography perspectives in drug analysis. , 1996, Journal of chromatography. A.

[5]  H. Fabre,et al.  Cross validation of capillary electrophoresis and high-performance liquid chromatography for cefotaxime and related impurities , 1996 .

[6]  H. Fabre,et al.  Capillary Electrophoresis as an Alternative Method for the Determination of Cefotaxime , 1995 .

[7]  P. Emaldi,et al.  Validation of a capillary electrophoresis method for the determination of cephradine and its related impurities , 1995 .

[8]  J. P. Pavón,et al.  Micellar liquid chromatography of zwitterions: retention mechanism of cephalosporins , 1995 .

[9]  C. Sciacchitano,et al.  Identification and separation of five cephalosporins by micellar electrokinetic capillary chromatography. , 1994, Journal of chromatography. B, Biomedical applications.

[10]  E. Roets,et al.  Synthesis of Related Substances of Cefadroxil , 1994 .

[11]  K. Altria.  Quantitative aspects of the application of capillary electrophoresis to the analysis of pharmaceuticals and drug related impurities , 1993 .

[12]  E. Roets,et al.  Comparative study of liquid chromatographic methods for the determination of cefadroxil , 1993 .

[13]  E. Roets,et al.  Column liquid chromatography of cefadroxil on poly(styrene divinylbenzene) , 1993 .

[14]  J. Hoogmartens,et al.  Experimental design on liquid chromatographic parameters in the analysis of tetracycline on poly(styrene-divinylbenzene). , 1993, Journal of pharmaceutical and biomedical analysis.

[15]  D. R. Bobbitt,et al.  Chromatographic analysis of antibiotic materials in food. , 1992, Journal of chromatography.

[16]  J. A. Nolan,et al.  Pharmaceutical Drug Separations by HPCE: Practical Guidelines , 1992 .

[17]  Lutgarde M. C. Buydens,et al.  RES, AN EXPERT SYSTEM FOR THE SET-UP AND INTERPRETATION OF A RUGGEDNESS TEST IN HPLC METHOD VALIDATION .1. THE RUGGEDNESS TEST IN HPLC METHOD VALIDATION , 1991 .

[18]  M. Nahata,et al.  Liquid chromatographic method for the determination of cefadroxil in its suspension and in serum , 1990 .

[19]  M. Rey,et al.  Determination of pharmaceuticals by multi-phase chromatography : combined reversed phase and ion exchange in one column , 1990 .

[20]  Desire L. Massart,et al.  Uniform shell designs for optimization in reversed-phase liquid chromatography , 1989 .

[21]  H. Fabre,et al.  Fluorescamine Post-Column Derivatization for the HPLC Determination of Cephalosporins in Plasma and Urine , 1988 .

[22]  J. Mcateer,et al.  Liquid-chromatographic determination of five orally active cephalosporins--cefixime, cefaclor, cefadroxil, cephalexin, and cephradine--in human serum. , 1987, Clinical chemistry.

[23]  E. Roets,et al.  Selectivity of reversed-phase packing materials in high-performance liquid chromatography of cephalosporins , 1984 .

[24]  A. Tsuji,et al.  Comparative stability of cephalosporins in aqueous solution: kinetics and mechanisms of degradation. , 1976, Journal of pharmaceutical sciences.