Bioequivalence and Analytical Validation of Linagliptin: A Comprehensive Study Using LC -MS/MS in Human Plasma

This study provides a detailed bioequivalence analysis and analytical validation of Linagliptin ۵ mg using human plasma samples. Employing a robust LC-MS/MS method with electrospray ionization (ESI) in positive ion mode, the study adheres to stringent guidelines to ensure reliability and reproducibility. The method validation followed the European Medicines Evaluation Agency (EMEA) and ICH M ۱۱ guidelines, encompassing parameters such as specificity, carry-over, lower limit of quantification (LLOQ), calibration, accuracy, precision, matrix effects, and stability. The LLOQ was determined at ۱۲۲۵ ppb, with a signal-to-noise ratio exceeding ۱۱. The calibration curve displayed linearity across ۱۲۲۵ to ۱۶ ppb with weighted regression. Intra- and inter-day accuracy and precision tests confirmed deviations below ۵۲.۵. Matrix effect evaluations using plasma from six different donors demonstrated consistent results with RSDs below ۱۲۲۵۵. Stability tests under various conditions, including short-term, freeze-thaw, and long-term, revealed no significant degradation, supporting the robustness of the assay. Additionally, pharmacokinetic profiles from human volunteers were analyzed, confirming bioequivalence between Linagliptin and the reference formulation. These findings highlight the method’s applicability for regulatory compliance and its potential for clinical and pharmaceutical research.

کلیدواژه ها:

Linagliptin ، Bioequivalence ، LC-MS/MS ، Analytical Validation ، Human Plasma ، ICH M ۰۱ Guidelines ، Matrix Effect ، Stability ، Pharmacokinetics