Abstract

Background: Cefixime is a cephalosporin antibiotic used for treatment of gonorrhoea and infections of the respiratory and urinary tracts.

Aim: Establishment of a bio-analytical method in order to quantify cefixime in plasma and investigate cefixime pharmacokinetics in human plasma and its application in clinical studies including comparative bioavailability studies.

Methods: After extraction of cefixime from human plasma, it was chromatographed with mobile phase consisting of methanol: 10mM ammonium acetate: acetonitrile (4/16/80) v/v/vat flow rate 0.63ml/min, ESI positive mode, and m/z 454à285, 396.1à277.2 for cefixime and cefdinir as an internal standard respectively. Clinical application as a bioequivalence study involving 26 volunteers in a crossover pattern and pharmacokinetic parameters AUC _0-t, AUC _0-inf, C_max, and T_max were used for assessment of bioequivalence of generic and reference products_.

Results: The developed bioanalytical method showed that the average recovery of Cefixime from human plasma was 92.259%. The limit of quantitation was 0.1ug/ml, and the correlation coefficient (r²) was 0.9994. Analysis of variance showed that there was no significant difference between generic and reference products.

Conclusion: The LC/MS/MS method presented is direct, simple, reproducible, sensitive, and linear for determination of cefixime in human plasma, and is suitable for clinical pharmacokinetic studies, clinical trials, and monitoring drug levels in plasma to ensure clinical efficacy and safety and to avoid therapeutic failure or incidence of adverse events. Moreover, generic product was found to provide the same rate and extent of drug absorption as the reference product.

Keywords: Cefixime; Plasma; COVID-19

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Citation

Citation: Nagwa A Sabri., et al. “Cefixime and Management Protocols for COVID-19 Second Wave. Does its Accurate Detection in Human Plasma Make Sense?". Acta Scientific Pharmaceutical Sciences 5.1 (2021): 46-53.

Copyright

Copyright: © 2021 Nagwa A Sabri., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.