Unique Liquid Chromatography Technique for Determining a New Selective PPARα Modulator Drug (Pemafibrate) in the Tablet Dosage Form, Robustness by Design Expert in the Light of Quality by Design

Abstract

This research study presents a precise, accurate, and linear liquid-chromatography method for the determination of pemafibrate in tablet dosage forms, despite the presence of a high volume of excipients. Various challenges were addressed through experimental approaches and evidence-based solutions. The method employs a suitable stationary phase, X-Bridge C₁₈ (150 × 4.6 mm, 3.5 μm), and an appropriate isocratic program. Key parameters include a flow rate of 1.0 mL/min, a column temperature of 40°C, an injection volume of 10 μL, and a runtime of 15 min. The wavelength was set at 210 nm because of its high response. Mobile phase optimization, based on experimental results, consists of 0.1% H₃PO₄ buffer and acetonitrile in a 40:60 v/v ratio. The method has been validated according to ICH Q2 (R2) and Ch. P <9101> guidelines, achieving a recovery rate of 99.1% to 100.5% at levels of 50%, 100%, and 150%. Linearity was demonstrated from 25% to 300% concentration levels, with a correlation coefficient (r²) value of 1.000. Precision results showed %RSD values of 1.0 and 1.1. Forced degradation studies indicated sensitivity to acid hydrolysis stress conditions and stability under physical stress conditions.