Quality by Design (QbD)–Based RP-HPLC Method Development and Validation for Apixaban
Pharmaceutical Quality Assurance, PRES's College of pharmacy (for women) Chincholi, Nashik, Maharashtra, India.
Research Article
International Journal of Biological and Pharmaceutical Sciences Archive, 2026, 12(01), 045–055.
Article DOI: 10.53771/ijbpsa.2026.12.1.0030
Publication history:
Received on 23 May 2026; revised on 11 July 2026; accepted on 14 July 2026
Abstract:
A robust reverse phase high-performance liquid chromatographic (RP-HPLC) method for the quantitative determination of apixaban was developed using a Quality by Design (QbD) approach. The Analytical Target Profile (ATP) was defined to achieve adequate resolution, acceptable retention time, and peak symmetry. Critical Method Parameters (CMPs) were identified and optimized using Design of Experiments (DoE) and statistical evaluation through Analysis of Variance (ANOVA). The optimized method was validated according to ICH Q2 guidelines and demonstrated suitable linearity, precision, accuracy, robustness, and stability-indicating capability. The developed method is suitable for routine quality control analysis of apixaban in bulk and pharmaceutical dosage forms.
Keywords:
Apixaban; Quality by Design; RP-HPLC; DoE; ANOVA; Method Validation
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