AQbD-assisted Hptlc Method for Simultaneous Determination of Bisoprolol Fumarate and Perindopril Arginine: Optimization, Validation and Comprehensive Sustainability Assessment
Year: 2026
Type: preprint
Abstract: Background The development of robust analytical methods is essential to ensure the quality, safety, and therapeutic efficacy of fixed-dose combination (FDC) pharmaceutical products. Objective In the present study, an Analytical Quality-by-Design (AQbD)-assisted high-performance thin-layer chromatographic (HPTLC) method was developed and validated for the simultaneous determination of bisoprolol fumarate (BIS) and perindopril arginine (PER) in tablet formulations. Method Critical method parameters affecting chromatographic performance were systematically optimized using a three-factor, three-level Box–Behnken experimental design to establish a scientifically justified analytical design space. The developed method was validated according to the International Council for Harmonisation (ICH Q2(R2)) guideline for specificity, linearity, accuracy, precision, robustness, detection capability, quantitation capability, and assay. Results Under the optimized chromatographic conditions, BIS and PER were well resolved with compact and symmetrical peaks, demonstrating excellent chromatographic performance. The method exhibited satisfactory linearity over the selected concentration ranges with high correlation coefficients, while recovery, precision, and robustness studies confirmed its reliability and reproducibility. Application of the optimized method to a marketed tablet formulation demonstrated accurate quantification of both analytes without interference from excipients. The developed method also demonstrated excellent analytical sustainability, achieving an AGREE score of 0.71, an Analytical Eco-Scale score of 81, and favourable GAPI and BAGI assessments. Furthermore, the RGB 12 evaluation yielded Redness, Greenness, and Blueness scores of 98.8%, 82.5%, and 89.6%, respectively, with an overall Method Brilliance score of 90.3%. Conclusion The integration of AQbD principles with HPTLC provided enhanced method understanding, improved robustness, and reduced experimental variability, demonstrating the suitability of the proposed method for routine quality control and regulatory applications in pharmaceutical analysis, confirming an excellent balance between analytical performance, environmental sustainability, and practical applicability.
Source: Research Square
Institutions: Gujarat Technological University, Parul University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7204934827