Abstract

ANALYTICAL QUALITY BY DESIGN (AQBD) BASED DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR FAVIPIRAVIR

*Mrs. Shital Jadhav

ABSTRACT

Analytical Quality by Design (AQbD) is a systematic, science-based, and risk-management-oriented approach for developing robust analytical methods. The concept emphasizes predefined objectives, process understanding, and control strategies to ensure consistent analytical performance. Favipiravir, a broad-spectrum antiviral drug extensively investigated for viral infections including COVID-19, requires reliable analytical methods for quality control and stability assessment. Reverse Phase High Performance Liquid Chromatography (RP-HPLC) remains one of the most widely used techniques for quantitative determination of favipiravir in bulk drugs and pharmaceutical formulations. This review discusses the principles of AQbD, method development strategies, risk assessment, experimental design, optimization, and validation of AQbD-based RP-HPLC methods for favipiravir. The review highlights the advantages of AQbD over conventional analytical approaches in achieving robust, efficient, and regulatory-compliant analytical methods.

Keywords: Analytical Quality by Design, AQbD, Favipiravir, RP-HPLC, Method Validation, Design of Experiments, Risk Assessment.