A paradigm for sustainable analysis: QbD-driven HPLC-DAD for triple antiallergics in pharmaceutical, biological, and...

This study introduces an innovative approach combining Quality by Design (QbD) principles with high-performance liquid chromatography and diode array detection (HPLC-DAD) for the simultaneous analysis of tranilast (TNL), pranoprofen (PPF), and chlorpheniramine maleate (CPM), a novel antiallergic combination therapy. The QbD framework was systematically employed to optimize critical method parameters, including mobile phase composition, flow rate, and column temperature, to achieve robust separation of the target analytes within a short analysis time. Method validation was conducted following ICH guidelines, demonstrating excellent linearity within the concentration range of 4-40, 2-50 and 1-140 μg/mL, with detection limits of 1.034, 0.661, and 0.328 μg/mL and quantitation limits of 3.133, 2.0, and 0.994 μg/mL for CPM, PPF, and TNL, respectively. The method was further applied to triple combination eye drops, aqueous humor, and environmental water samples, with a recovery of > 97 %. The application of QbD enhanced the method's reliability and confirmed consistent performance. A holistic sustainability assessment confirmed the method's environmental and economic viability, featuring low solvent use, minimal sample preparation, and long-term durability, in line with green analytical chemistry principles. This integrated strategy provides an efficient solution for the quality control of complex ophthalmic formulations, facilitating the development of safer and more effective antiallergic therapies.