Comparación bibliográfica de técnicas cromatográficas para la detección de impurezas orgánicas en medicamentos genéricos

Abstract

Abstract: This investigation had the objective of conducting a bibliographical comparison of chromatographic methods employed for the identification of organic contaminants within generic pharmaceuticals. Our exploration was undertaken via a systematic review grounded in the PRISMA 2020 and PRISMA-S guidelines, incorporating a qualitative and comparative appraisal of scientific publications and official documentation. The resultant data reveals that LC-MS/MS and LC-HRMS demonstrate superior efficacy for the detection of nitrosamines and genotoxic impurities at extremely low concentrations, owing to their enhanced sensitivity, specificity, and definitive power. HPLC/UPLC continues to serve a valuable purpose in analyzing degradation products and impurities stemming from manufacturing processes, whereas GC and Headspace-GC prove more adept at characterizing residual solvents and volatile substances. The comparison also showed that the pharmaceutical matrix modifies method performance, especially in solid, liquid and special dosage forms. It is concluded that method selection should be based on impurity type, matrix, regulatory limit and analytical purpose, rather than on a single hierarchy among techniques.