Analytical Quality by Design-Driven RP-HPLC Method Conditions to Concomitantly Determine Cinnarizine and Morin Hydrate in Combined Drug Solution and Dual Drug-Loaded Formulations.

This article focuses on the development and validation of an analytical quality by design (AQbD)-driven reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of cinnarizine (CNZ) and morin hydrate (MH) in combined drug solutions and dual-drug-loaded emulsion-like dispersions intended for managing Ménière’s disease (MD). The study optimized critical method attributes using systematic risk assessment and design of experiments, achieving validated chromatographic conditions with retention times of 5.017 and 5.323 minutes for CNZ and MH, respectively, and compliance with International Council for Harmonisation (ICH) guidelines. The method demonstrated specificity, precision, accuracy, and robustness, and was successfully applied to quantify drug entrapment efficiency and in vitro release from oil-less emulsion-like dispersions using a camphor-menthol eutectic mixture as the carrier. The research highlights the potential of AQbD approaches for optimizing RP-HPLC methods for simultaneous drug analysis in complex formulations.