Development, Validation and Green Analytical Assessment of a Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Glycopyrronium, Vilanterol and Fluticasone Furoate in Capsule Dosage Form

Abstract

For simultaneous evaluation of glycopyrronium, vilanterol, and fluticasone furoate in capsules, an Inertsil ODS C18 column was used to develop a reverse-phase HPLC technique. Acetonitrile (ACN) and 0.1% triethylamine (Et3N), pH 2.5, were used as a mobile phase in a 20:80 volumetric ratio to achieve separation with 1.0ml/min, at retention times of about 2.25, 3.02 and 4.38min for glycopyrronium, vilanterol and fluticasone furoate, respectively, with detection at 250nm. Validation in compliance with ICH guidelines verified adequate accuracy, precision, linearity, specificity and robustness, and forced degradation findings confirmed that the method was stability-indicating and sufficient for pharmacopeial quality control of the marketed formulation. Green assessment using the AGREE tool yielded a score of 0.58, supporting its routine use for quality control and stability evaluation of this triple combination.