Optimizing Mirabegron Stability in Human Plasma: Method Development, Validation Through Integration of Esterase...

Area of Science:

• Analytical Chemistry
• Pharmacology
• Biochemistry

Background:

• Mirabegron stability in human plasma is crucial for accurate quantification.
• Enzymatic and oxidative degradation poses challenges to mirabegron analysis.
• Development of stabilizing agents and inhibitors is necessary for reliable bioanalysis.

Purpose of the Study:

• To develop and validate a stability-indicating analytical method for mirabegron in human plasma.
• To assess the efficacy of various inhibitors and stabilizers in preventing mirabegron degradation.
• To ensure the method's suitability for bioequivalence testing, therapeutic drug monitoring, and pharmacokinetic studies.

Main Methods:

• Sample preparation involved solid-phase extraction (SPE) using Strata-X cartridges.
• Chromatographic separation was optimized on a C18 Kromasil column with an ammonium formate and acetonitrile mobile phase.
• Detection was performed using electrospray ionization (ESI) in positive mode with multiple reaction monitoring (MRM).

Main Results:

• The method demonstrated high accuracy (95.67%–102.85%) and precision (0.52%–2.31%).
• Linearity was established over a range of 0.100 to 102.496 ng/mL.
• The validated method requires minimal plasma volume (100 μL), has a short runtime (3 min), and achieves high recovery (92.93%).

Conclusions:

• A robust and efficient analytical method for mirabegron stability in human plasma was successfully developed.
• The method's stability, speed, and minimal sample requirement make it ideal for clinical applications.
• This validated assay is suitable for bioequivalence testing, therapeutic drug monitoring, and pharmacokinetic studies.