Comparison of micellar electrokinetic chromatography, liquid chromatography, and microbiologic assay for analysis of cephalexin in oral suspensions

• Published in: Journal of AOAC International 2003-07, Vol.86 (4), p.707-713
• Main Authors: STEPPE, Martin, PRADO, Maria S, TAVARES, Marina F. M, PINTO, Teresinha J. A, KEDOR-HACKMANN, Erika R. M, SANTORO, Maria Inês R. M
• Format: Article
• Language: English
• Subjects: Anti-Bacterial Agents - analysis; Biological and medical sciences; Biological Assay - methods; Cephalexin - analysis; Chromatography, Liquid - methods; Chromatography, Micellar Electrokinetic Capillary - methods; Food industries; Fundamental and applied biological sciences. Psychology; General aspects; Methods of analysis, processing and quality control, regulation, standards; Pharmaceutical Preparations - chemistry; Quality Control; Reproducibility of Results; Sensitivity and Specificity; Staphylococcus aureus; Staphylococcus aureus - drug effects
• ISSN: 1060-3271; 1944-7922
• DOI: 10.1093/jaoac/86.4.707

Two well-accepted methodologies, based on a microbiologic assay (MA) and liquid chromatography (LC), and a novel methodology using micellar electrokinetic chromatography (MEKC), were compared for the determination of cephalexin in commercially available and simulated samples of oral suspensions. The MA, described in the Brazilian Pharmacopeia, was performed with a strain of Staphylococcus aureus ATCC 6538 as the test organism, following the cylinder-plate method. The LC analysis followed the European Pharmacopoeia, 3rd Ed., and was used with minor modifications. The MEKC analysis was based on a previous work of the group. Estimates of the repeatability relative standard deviations of the MA, LC, and MEKC methods in the analysis of a commercial sample were 0.34, 0.42, and 0.37%, respectively. The recovery obtained with LC was 99.90 +/- 1.11%; for MEKC, it was 100.09 +/- 0.56%. Although the 3 methodologies were statistically equivalent for the determination of cephalexin in oral suspensions, MA gave suitable repeatability despite being nonspecific and time-consuming. MEKC provided faster analysis and higher column efficiency, whereas LC presented superior sensitivity. The results indicated that MEKC can be used as an alternative method to MA and LC in routine quality control laboratories.