Speaker
Description
Antibiotics, particularly cephalosporins, represent an importat group of drugs with wide application in modern medicine. Cefixime, a semisystetic third generation cephalosporin, is commonly used in the form of an oral suspension, where sodium benzoate is used as a chemical preservative. Existing internal quantification procedures are based on separate analytical methods employing different chromatographic conditions due to the differing nature of the active substance and the preservative.
The aim of this study is development, optimization and validation of a simple, rapid, sensitive and specific HPLC method for simultaneous determination of cefixime and sodium benzoate in oral suspensions. Several HPLC and UHPLC columns were evaluated, with detailed assessment of their performance in terms of resolution, efficiency, stability and durability. The results demonstrated that the UHPLC columns, although enabling faster analysis, do not provide sufficient robustness when analyzing a complex, sugar-rich matrix, like the oral suspension, which limits their suitability for routine quality control applications. The HPLC Waters XBridge C18 column proved to be the most appropriate, providing stable and reproducible chromatography, satisfactory resolution, appropriate peak shape and short analysis time. Furthermore, forced degradation studies under acidic, basic and oxidative conditions confirmed the specificity and selectivity of the developed method. In addition, the method was validated according to relevant ICH guidelines, including evaluation of linearity, accuracy, precision, specificity, filtration effects, stability, and robustness. 1, 2
The obtained results indicate that the proposed HPLC method is suitable for routine use in quality control laboratories as well as for regulatory purposes.