Quantification of Bempedoic Acid and Ezetimibe with Comprehensive Stability Assessment in Drug Substance and Drug Product by UPLC

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A validated UPLC method quantifies bempedoic acid and ezetimibe in drug substances, highlighting stability assessment.

The UPLC method enables precise quantification of bempedoic acid and ezetimibe, ensuring quality analysis.
Stability tests revealed both compounds are sensitive to acidic, oxidative, and thermal conditions.
Validation confirmed method efficacy, with high recovery rates and low limits of detection for both drug compounds.
The method consistently met ICH Q2(R1) standards, ensuring reliability for quality control in pharmacological settings.

Reddemma et al. (2025) studied this question.

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