Systematic AQbD Approach to UPLC Method Development for Elacestrant and Pirtobrutinib

The evolution of pharmaceutical analysis has led to the integration of Analytical Quality by Design (AQbD). This strategic framework enhances the robustness, reliability, and regulatory compliance of analytical methods. This review focuses on the AQbD-based development and validation of a novel Ultra Performance Liquid Chromatography (UPLC) method for the simultaneous estimation of Elacestrant and Pirtobrutinib in bulk and pharmaceutical dosage forms. Elacestrant, a selective estrogen receptor degrader, and Pirtobrutinib, a nextgeneration Bruton's tyrosine kinase (BTK) inhibitor, are emerging anticancer agents requiring precise and accurate analytical methods for quality control

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-05-25
DOI
https://doi.org/10.5281/zenodo.15510519
Primary Topic
Computational Drug Discovery Methods
Type
article
Field-Weighted Citation Impact
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article

Systematic AQbD Approach to UPLC Method Development for Elacestrant and Pirtobrutinib

Zenodo (CERN European Organization for Nuclear Research)
Computational Drug Discovery Methods
article

Systematic AQbD Approach to UPLC Method Development for Elacestrant and Pirtobrutinib

article en

Abstract

The evolution of pharmaceutical analysis has led to the integration of Analytical Quality by Design (AQbD). This strategic framework enhances the robustness, reliability, and regulatory compliance of analytical methods. This review focuses on the AQbD-based development and validation of a novel Ultra Performance Liquid Chromatography (UPLC) method for the simultaneous estimation of Elacestrant and Pirtobrutinib in bulk and pharmaceutical dosage forms. Elacestrant, a selective estrogen receptor degrader, and Pirtobrutinib, a nextgeneration Bruton's tyrosine kinase (BTK) inhibitor, are emerging anticancer agents requiring precise and accurate analytical methods for quality control

Zenodo (CERN European Organization for Nuclear Research)
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Computational Drug Discovery Methods
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Systematic AQbD Approach to UPLC Method Development for Elacestrant and Pirtobrutinib · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS