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March 18, 2026Open Access

Application of Analytical Quality by Design in Chromatographic Method Development: A Pharmaceutical Perspective

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Authors

SBSiddhi Kadam*1, Amruta Ghule2, Prof. R. S. Bandal3

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Overview

This review explores the AQbD approach for enhancing chromatographic methods in pharmaceuticals, highlighting its advantages.

Key Points

  • The aim is to evaluate the application of Analytical Quality by Design (AQbD) in developing chromatographic methods for pharmaceuticals.
  • Review of AQbD framework and its components in chromatographic methods.
  • Identification of critical quality attributes and critical method parameters.
  • Use of design of experiments for optimizing chromatographic conditions.
  • AQbD enhances method reliability and robustness compared to traditional approaches.
  • Facilitates compliance with regulatory expectations for pharmaceutical products.
  • Supports consistent quality and safety in pharmaceutical methods.

Cite This Study

Siddhi Kadam*1, Amruta Ghule2, Prof. R. S. Bandal3 (2026) studied this question.

synapsesocial.com/papers/69ba43b64e9516ffd37a533ehttps://doi.org/10.5281/zenodo.19043257
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  3. 3ANALYTICAL QUALITY BY DESIGN (AQBD) IN THE DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHODS FOR FIXED-DOSE COMBINATIONS: A COMPREHENSIVE REVIEW2026
  4. 4QUALITY BY DESIGN (QBD) IN ANALYTICAL METHOD DEVELOPMENT: A SYSTEMATIC REVIEW OF PRINCIPLES, TOOLS AND REGULATORY PERSPECTIVES2026
  5. 5A COMPREHENSIVE REVIEW ON ADVANCING PHARMACEUTICAL ANALYSIS THROUGH ANALYTICAL QUALITY BY DESIGN (AQBD)2026