HPLC Method Development and Validation for Estimation of Fluticasone Furoate & Vilanterol Trifenatate in Bulk and Dosage Form by Using Quality by Design Approach

A novel, sensitive, and robust High-Performance Liquid Chromatography (HPLC) method was developed and validated for the simultaneous estimation of Fluticasone furoate and Vilanterol trifenatate, adhering to the principles of Quality by Design (QbD). This research addresses the need for a reliable analytical method for the quality control of these co-formulated drugs. The QbD approach was systematically applied, beginning with the definition of an Analytical Target Profile (ATP) to establish the method's performance criteria. A comprehensive Risk Assessment, guided by tools like the Ishikawa diagram, identified potential Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) that could impact method performance. A Box-Behnken Design of Experiment (DoE) was employed to optimize the method and understand the interaction of these critical parameters, leading to the identification of a robust Design Space. The developed method utilizes a Kromasil C18 column (250 mm×4.6 mm, 5 µm), with a mobile phase of methanol and 0.1% orthophosphoric acid (OPA) in water (80:20 v/v), delivered at a flow rate of 0.9 mL/min. Detection was performed at a wavelength of 264 nm. This method successfully achieved well-resolved peaks for both Fluticasone furoate and Vilanterol trifenatate, with retention times of 4.289 and 2.876 minutes, respectively. The method was then validated according to ICH guidelines, confirming its specificity, precision, accuracy, linearity, and robustness. The application of the QbD approach ensured the method's ruggedness and reliability, making it suitable for routine analysis in both bulk drug substances and pharmaceutical formulations. This study provides a significant contribution to the quality control of these vital respiratory drugs by establishing a scientifically sound and highly reliable analytical method.