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