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April 12, 2026Open Access

STRATEGIC IMPLEMENTATION OF ANALYTICAL QUALITY BY DESIGN (AQbD) IN HPLC METHOD DEVELOPMENT FOR PHARMACEUTICAL QUALITY ASSURANCE: A COMPREHENSIVE REVIEW

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Authors

LGLalit Kumar*, Hitesh Kothari, Anju Goyal

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Overview

This review evaluates AQbD's impact on HPLC method reliability in pharmaceuticals, suggesting its essential role in quality assurance.

Key Points

  • The aim is to evaluate how AQbD improves the robustness and reliability of HPLC methods in pharmaceuticals.
  • Literature review of developments from 2016 to 2025.
  • Systematic synthesis of articles from Scopus, Web of Science, and PubMed.
  • Analysis of the integration of ICH Q9 and statistical optimization methods.
  • Traditional methods often have robustness gaps, leading to Out-of-Specification results.
  • AQbD provides structured frameworks like ATP and MODR for built-in quality assurance.
  • The new ICH Q14 guidelines support a modern regulatory pathway for implementing AQbD.

Cite This Study

Lalit Kumar*, Hitesh Kothari, Anju Goyal (2026) studied this question.

synapsesocial.com/papers/69db37df4fe01fead37c603chttps://doi.org/10.5281/zenodo.19494061
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A COMPREHENSIVE REVIEW ON ADVANCING PHARMACEUTICAL ANALYSIS THROUGH ANALYTICAL QUALITY BY DESIGN (AQBD)2026
  2. 2ANALYTICAL QUALITY BY DESIGN (AQBD) IN THE DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHODS FOR FIXED-DOSE COMBINATIONS: A COMPREHENSIVE REVIEW2026
  3. 3QUALITY BY DESIGN (QBD) IN ANALYTICAL METHOD DEVELOPMENT: A SYSTEMATIC REVIEW OF PRINCIPLES, TOOLS AND REGULATORY PERSPECTIVES2026
  4. 4Analytical Quality-by-Design approach for HPLC analysis of pharmaceutical mixtures: case studies2024
  5. 5ANALYTICAL QUALITY BY DESIGN (AQBD) APPROACH FOR LIFECYCLE MANAGEMENT OF PHARMACEUTICAL ANALYTICAL METHODS2026