Advanced Analytical Assessment of Cefixime in Human Plasma: Method Development, Validation, and Bioequivalence Analysis

This study introduces a highly sensitive and precise LC-MS/MS method for the quantification of cefixime in human plasma, facilitating bioequivalence assessments of pharmaceutical formulations. Employing an internal standard (cefalexin), the method demonstrated robust analytical performance, aligning with ICH M۱۰ and EMEA guidelines. The calibration curve showed excellent linearity across a range of ۵۰–۱۲,۰۰۰ ppb, with a correlation coefficient consistently exceeding ۰.۹۹. Specificity tests revealed negligible interference, ensuring accurate differentiation between cefixime and endogenous plasma components. Method validation parameters, including intra- and inter-day precision (%RSD < ۱۰%) and accuracy, underscored the reliability of the protocol. The validated method was applied in a bioequivalence study with ۲۶ healthy volunteers, where plasma samples were analyzed over a ۲۴-hour period post-dosing. Pharmacokinetic parameters such as Cmax, Tmax, and AUC were comparable between test and reference formulations, confirming bioequivalence. The findings highlight the efficacy of this method for bioanalytical applications and its potential to streamline clinical drug evaluation processes.

کلیدواژه ها:

Cefixime ، Bioequivalence ، LC-MS/MS ، Pharmacokinetics ، Analytical Method Validation ، Human Plasma Analysis