Strategies for the development and optimization of green acetonitrile-free HPLC methods for application in pharmaceutical analysis

IF 4.9 2区化学 Q1 CHEMISTRY, ANALYTICAL

Microchemical Journal Pub Date : 2025-04-15 DOI:10.1016/j.microc.2025.113659

Gabriela Lemos Ribeiro de Souza , Amanda de Paula Oliveira , Paulo Salles Neto , Jhonatan Bispo de Oliveira , Cassiano Lino dos Santos Costa , Patterson Patricio de Souza , Marina Bicalho Silveira , Ildefonso Binatti

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Abstract

In the pharmaceutical industry, high-performance liquid chromatography (HPLC) is of central importance for quality control and the analysis of active pharmaceutical ingredients. Conventional HPLC methods commonly use acetonitrile (ACN) due to its favorable properties, but it’s expensive, toxic, and causes environmental damage, making it necessary to look for safer alternatives. This study presents a systematic approach to developing and optimizing an HPLC pharmaceutical analysis method by replacing ACN and phosphate buffer with methanol and trifluoroacetic acid (TFA). The method was validated for the purity analysis of the radiopharmaceutical PSMA-1007 (¹⁸F) and demonstrates a change towards more environmentally friendly methods in chromatographic analysis. Using multivariate experimental designs, the method was optimized to achieve efficient separation with methanol and TFA. The new method showed comparable performance to conventional methods, is cheaper, and offers environmental benefits such as lower solvent toxicity and lower ecological impact. This work emphasizes the importance of integrating green chemistry principles into method development and provides a guide for applying these practices to various pharmaceutical analyses.

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来源期刊

Microchemical Journal 化学-分析化学

CiteScore

8.70

自引率

8.30%

发文量

1131

审稿时长

1.9 months

期刊介绍： The Microchemical Journal is a peer reviewed journal devoted to all aspects and phases of analytical chemistry and chemical analysis. The Microchemical Journal publishes articles which are at the forefront of modern analytical chemistry and cover innovations in the techniques to the finest possible limits. This includes fundamental aspects, instrumentation, new developments, innovative and novel methods and applications including environmental and clinical field. Traditional classical analytical methods such as spectrophotometry and titrimetry as well as established instrumentation methods such as flame and graphite furnace atomic absorption spectrometry, gas chromatography, and modified glassy or carbon electrode electrochemical methods will be considered, provided they show significant improvements and novelty compared to the established methods.