Advanced Analytical Method Validation for Bioequivalence Studies of Fexofenadine in Human Plasma Using LC -MS/MS

This study presents a comprehensive bioequivalence analysis of fexofenadine in human plasma samples, employing an advanced LC-MS/MS technique. The method was meticulously validated in compliance with the ICH M۱۱ guidelines, focusing on specificity, linearity, precision, accuracy, and robustness. Calibration curves were constructed over a concentration range of ۱۲۶۲۵–۳۱۱ ppb, exhibiting high linearity (R > ۱۲۹۹). Specificity assessments demonstrated negligible interference, ensuring the method’s reliability in detecting analyte and internal standard signals. Clinical application involved the analysis of plasma samples from volunteers administered test and reference formulations, with pharmacokinetic parameters such as Cmax and Tmax compared. The results confirmed the bioequivalence of the two formulations, as indicated by comparable pharmacokinetic profiles and low intra-individual variability. This validated method and its findings provide a robust framework for the bioequivalence assessment of fexofenadine and similar pharmaceutical compounds, supporting regulatory approval and clinical application.

کلیدواژه ها:

Fexofenadine ، Bioequivalence ، LC-MS/MS ، Analytical Method Validation ، Pharmacokinetics