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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开发和优化用于药物分析的绿色无乙腈高效液相色谱法的策略

在制药工业中，高效液相色谱法（HPLC）对于质量控制和有效药物成分的分析至关重要。传统的高效液相色谱方法通常使用乙腈（ACN），因为它具有良好的性能，但它昂贵，有毒，并且会造成环境破坏，因此有必要寻找更安全的替代品。以甲醇和三氟乙酸（TFA）代替ACN和磷酸盐缓冲液，建立并优化了高效液相色谱药物分析方法。该方法在放射性药物PSMA-1007 （18F）的纯度分析中得到验证，表明色谱分析方法向更环保的方向发展。通过多因素实验设计，优化了该方法，使其能够与甲醇和TFA有效分离。新方法的性能与传统方法相当，成本更低，并且具有低溶剂毒性和低生态影响等环境效益。这项工作强调了将绿色化学原理整合到方法开发中的重要性，并为将这些实践应用于各种药物分析提供了指导。

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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.