Analytical Method Validation in Pharmaceutical Quality Control: Current Guidelines and Challenges

Abstract

Analytical method validation (AMV) in the veterinary field forms an important aspect of quality control in pharmaceutical companies in which drugs are used to treat various species of animals to guarantees safety, efficacy and regulatory actions are adhered to. This review points to the significance of the species-based approaches in pharmacokinetics of drug absorption, distribution, metabolism, and residue detection with a focus on the issues of physiological diversity, complex biological samples and ethical requirement. Modern methods such as HPLC, UPLC, GC, LC-MS/MS, UV-Vis, and FTIR are characterized by sensitivity, specificity, and reproducibility and newer techniques such as capillary electrophoresis and microfluidic-based technology, high-resolution mass spectrometry and bioinformatics-directed validation incorporates enhanced sensitivity, specificity, reproducibility, reduced sample volumes, and increased throughput. Future methodological advances in multi-dimensional platforms, green analytical chemistry, chemometrics, and machine learning offer new ways of addressing matrix effects and resource limitations and regulatory limitations. Taken together, these strategies can contribute to effective veterinary drug monitoring, food safety, and sustainable and species-specific AMV practices and direct future research at achieving harmonized and technologically more advanced validation processes.