Comparative analysis of chromatographic techniques for active pharmaceutical ingredients

Abstract

The pharmaceutical industry is a highly regulated sector where quality, safety, and efficacy of medications are fundamental priorities. To meet these stringent regulatory standards, the industry employs advanced analytical techniques such as chromatography. This study aims to conduct a bibliographic survey of chromatographic techniques used in the analysis of solid active pharmaceutical ingredients (APIs). Initially, a survey was conducted in a pharmaceutical company in western Paraná to identify the most analyzed solid APIs by chromatographic techniques over the last seven months, from July 2023 to January 2024. The main solid APIs identified were albendazole, atenolol, prednisolone sodium phosphate, furosemide, and metformin hydrochloride. Based on the guidelines established by official pharmacopeias, such as the Brazilian, British, and American pharmacopeias, the main chromatographic techniques used include High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Thin-Layer Chromatography (TLC). The bibliographic review covered the analyses currently using chromatographic techniques for each of these APIs, as well as the techniques that have been replaced over time. The research was conducted using pharmacopeial databases to obtain detailed information on the evaluation methods of these APIs, ensuring the safety and efficacy of the medications. For each evaluated API, it was found that HPLC is used for all APIs. Thus, the HPLC technique ensures compliance with rigorous regulatory standards and contributes to the safety and efficacy of medications, while the applicability of TLC and GC techniques depends on the official compendia and their physicochemical characteristics.