Bioequivalence Study of Eplerenone: Analytical Validation in Human Plasma Using LC -MS/MS

This study presents a comprehensive bioequivalence analysis of eplerenone in human plasma, employing liquid chromatography-tandem mass spectrometry (LC-MS/MS) for quantitation. Eplerenone, an aldosterone antagonist, is analyzed for pharmacokinetic equivalence between test and reference formulations. Method development and validation adhere to regulatory guidelines, emphasizing parameters such as specificity, carry-over, linearity, precision, and stability. Stock and working solutions were prepared for both eplerenone and dexamethasone (internal standard), followed by plasma sample spiking for calibration and testing. Analytical method validation confirmed a linear response over the range of ۵–۴۴۴۴ ppb, with a lower limit of quantitation (LLOQ) at ۱ ppb. The specificity tests showed no significant interference, and the carry-over effect was negligible. Accuracy and precision evaluations revealed intra- and inter-day variability within acceptable limits, ensuring reproducibility. Matrix effects were assessed using plasma from multiple donors, confirming the robustness of the method. Short-term and freeze-thaw stability studies validated sample integrity under laboratory conditions. Pharmacokinetic data from volunteer studies demonstrated comparable plasma concentration profiles between the test and reference products, confirming bioequivalence. This validated LC-MS/MS method demonstrates high sensitivity, specificity, and reliability for bioequivalence studies of eplerenone, offering significant contributions to pharmaceutical development and regulatory compliance.

کلیدواژه ها:

Eplerenone ، Bioequivalence ، LC-MS/MS ، Analytical Validation ، Pharmacokinetics ، Plasma Analysis ، Regulatory Guidelines