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@article{208561,
        author = {P. K. Tijare and N. I. Kochar and O.S. Bilone and A. V. Chandewar},
        title = {Development and Validation of HPLC method for Estimation of Multidrug Formulations Using Quality by Design Approach: A Review},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {4},
        pages = {2008-2016},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=208561},
        abstract = {Multidrug and fixed-dose combination formulations offer therapeutic and patient-convenience advantages but present significant analytical challenges due to differences in the physicochemical and chromatographic properties of multiple active pharmaceutical ingredients (APIs). Conventional one-factor-at-a-time HPLC development may require extensive experimentation and provides limited understanding of interactions among method variables. Analytical Quality by Design (AQbD) offers a systematic, science- and risk-based approach for developing robust and reliable chromatographic methods. This review discusses the application of AQbD to HPLC method development and validation for multidrug formulations, with emphasis on the Analytical Target Profile, critical analytical attributes, risk assessment, critical method parameters, Design of Experiments (DoE), response surface methodology, chromatographic optimization, Method Operable Design Region (MODR), control strategy, validation, and stability-indicating capability. Applications of factorial, screening, central composite, and Box–Behnken designs in simultaneous pharmaceutical analysis are critically considered. Integration of ICH Q14 and ICH Q2(R2) principles, together with green analytical chemistry, automation, chemometrics, and analytical lifecycle management, provides a contemporary framework for efficient and sustainable analytical procedure development. The review highlights the potential of AQbD to improve method understanding, robustness, reliability, and lifecycle performance for multidrug pharmaceutical formulations.},
        keywords = {Analytical Quality by Design; AQbD; HPLC; multidrug formulation; Design of Experiments; Central Composite Design; Method Operable Design Region; method validation;},
        month = {September},
        }