Advanced Bioequivalence Assessment of Celecoxib ۲۰۰ mg in Human Plasma: Analytical Validation and Matrix Effect Insights

This study focuses on the bioequivalence assessment of Celecoxib ۲۰۰ mg, conducted through a robust analytical approach employing LC-MS/MS. Method validation adhered to international guidelines, addressing parameters such as specificity, carry-over, linearity, precision, accuracy, matrix effects, and stability. Calibration was linear within ۵–۲۰۰۰ ppb, and LLOQ was established at ۵ ppb with a signal-to-noise ratio exceeding ۱۰. Validation results demonstrated method reliability, with within-run and between-run precision and accuracy falling within acceptable ranges (<۱۰% RSD). Matrix effect evaluation across six plasma sources showed negligible interference, affirming method consistency. Stability studies confirmed analyte integrity under short-term, freeze-thaw, and long-term conditions. The findings underscore the analytical method's suitability for assessing the pharmacokinetics of Celecoxib in bioequivalence trials. Additionally, this validated framework provides a basis for reliable drug monitoring and bioavailability studies, ensuring compliance with regulatory standards and advancing clinical pharmacology research.

کلیدواژه ها:

Celecoxib ، LC-MS/MS ، bioequivalence ، analytical validation ، pharmacokinetics ، matrix effects ، stability testing ، precision ، accuracy ، LLOQ