Abstract

Chemometric models, which integrate statistical and mathematical approaches with chemical data, are increasingly vital in optimizing bioanalytical techniques for drug quality control and regulatory compliance. This article explores how these models enhance the accuracy, efficiency, and robustness of methods such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and spectroscopy in pharmaceutical analysis. By addressing challenges like complex data interpretation, method variability, and regulatory stringency, chemometrics ensures drug safety and efficacy. Results from recent applications demonstrate improved detection limits, reduced analysis times, and compliance with standards like those of the FDA and ICH. The discussion highlights the transformative potential of these models, alongside limitations such as model complexity and data quality requirements, positioning chemometrics as a key tool in modern pharmaceutical science.