Revisión bibliográfica de los métodos analíticos: cromatografía, espectrometría y electroforesis utilizados para la identificación de impurezas en medicamentos

Abstract

Abstract: Pharmaceutical impurity control is a central requirement of quality assurance, with direct implications for patient safety. This systematic review analyzed evidence published between 2021 and 2026 on the analytical performance of four instrumental techniques: high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS) and capillary electrophoresis (CE), as applied to the identification of organic, inorganic and residual solvent impurities in pharmaceutical products. The PRISMA 2020 declaration was used to pick 22 studies of high or moderate quality from PubMed, Scopus and Web of Science. These studies were chosen because they are good, with no single technique is better than the others all the time. When we compare the validation parameters set by ICH Q2(R2) we see that HPLC is the way to find related organic impurities. The GC method is the way to find residual solvents. ICP-MS is the way to find elemental impurities. CE is the best metod to do enantiomeric analysis and biopharmaceutical charge variant profiling. We are talking about the PRISMA 2020 declaration and techniques like HPLC and GC and ICP-MS and CE. The PRISMA 2020 declaration helps us to select studies like these 22 studies, from PubMed and Scopus and Web of Science. The physicochemical characteristics of impurity and the relevant ICH regulatory framework determine the best approach to use. In today's pharmaceutical manufacturing, analytical complementarity turns out to be the best approach for thorough quality control.