eng Oriental Scientific Publishing Company Biosciences Biotechnology Research Asia 0973-1245 2026-03-30 23 1 204 220 10.13005/bbra/3491 58360 article Kajal Baviskar 1 Ramanlal Kachave 2 Machindra Chavan 3 Department of Pharmaceutical Chemistry, Amrutvahini College of Pharmacy, affiliated to Savitribai Phule Pune University, Maharashtra, India Department of Pharmaceutical Chemistry, GES’s Sir Dr. M. S. Gosavi College of Pharmaceutical Education and Research, affiliated to Savitribai Phule Pune University, Maharashtra, India Department of Pharmacognosy, Amrutvahini College of Pharmacy, affiliated to Savitribai Phule Pune University, Maharashtra, India The  study covers the Analytical Quality by Design driven method for the determining  Fimasartan, an antihypertensive drug. Critical Quality Attributes, namely, retention time, peak area and theoretical plates, were identified and assessed for method performance. An Ishikawa diagram along with Failure Mode Effects Analysis were employed to analyze risk and identify variables having a significant impact on method performance as well as reliability. Critical Method Variables, namely, mobile phase composition, flow rate, and detection wavelength, were systematically optimized. The chromatographic conditions after optimization were methanol proportion in mobile phase: 79.59%v/v, flow rate of 0.8 mL min^-1 and detection wavelength 264 nm. These conditions resulted in a response time of 5.5 min., with adequate system suitability, comprising adequate theoretical plates and peak symmetry. Validation of optimized method was accomplished using the ICH Q2 (R1) guidelines with consideration of recent revisions in Q2(R2)., displaying high linearity, accuracy, precision, and robustness. Precision data revealed that %RSD values that were well within acceptable ranges, indicating reproducibility of the method. Integration of Analytical Quality by Design allowed for a comprehensive understanding of method variability and control techniques. Such techniques can be utilized for chromatographic estimation of other drugs. https://www.biotech-asia.org/vol23no1/analytical-quality-by-design-driven-reversed-phase-high-performance-liquid-chromatography-method-and-risk-mitigation-for-fimasartan/ AQbD; Box Behnken Design; Critical Method Variables; Fimasartan; Risk Assessment