重新定义药物定量分析方法的绿色:一种多用途新型janus激酶抑制剂的案例研究

IF 6.2
Sagar Suman Panda
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引用次数: 0

摘要

绿色度已经成为分析化学领域的一个流行术语,在测量方法的绿色度方面取得了重大进展。一些较新的方法正在探索测量新开发的分析程序的绿色度的不同实际方面。然而,对旧方法进行回顾性绿色评估对于在监管框架内实现可持续的方法性能是有益的和具有成本效益的。当前的研究强调了使用各种现有的绿色指标来评估绿色的重要性。此外,它提出了一个案例研究,评估绿色的各种报道的方法和新开发的系统红外光谱方法的新药,巴比替尼。设计的实验导向红外方法开发为优化和验证方法提供了一个强大的框架,确保结果的鲁棒性和可靠性,同时最大限度地减少资源需求、总体开发时间和方法失败。该方法的线性度、准确度和精密度均可接受,不需要进行复杂的样品制备。最后,它处理了若干实际的挑战和差距,这些挑战和差距可以通过对现有程序进行一些必要的修订来克服。总之,这项研究提高了分析师社区对采用绿色度量方法的重要性的认识,对于新开发的方法和现有的方法,为了在整个方法生命周期中实现预定义的方法性能并支持绿色倡议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Redefining the greenness of quantitative analytical methods for drugs: A case study of a multipurpose novel janus kinase inhibitor

Redefining the greenness of quantitative analytical methods for drugs: A case study of a multipurpose novel janus kinase inhibitor
Greenness has become a popular term in the field of analytical chemistry, with significant advancements in measuring the greenness of methods. Several newer approaches are exploring the different practical aspects of measuring the greenness of newly developed analytical procedures. However, conducting a retrospective greenness assessment of older methods can be beneficial and cost-effective in achieving sustainable method performance within the regulatory framework. The current study highlights the significance of evaluating greenness using various existing greenness metrics. Furthermore, it presents a case study that assesses the greenness of various reported methods and a newly developed systematic infrared spectroscopic method for a novel drug, baricitinib. The designed experiments-oriented infrared method development offered a robust framework for optimizing and validating the method, assuring robustness and reliability of results while minimizing resource demand, overall developmental time, and method failure. The recent method's linearity, accuracy, and precision were acceptable, and sophisticated sample preparation was not required. Finally, it addresses several practical challenges and gaps that can be overcome by some of the necessary revisions in the existing procedures. In summary, this study raises awareness among the analyst community about the importance of adopting the greenness metrics approach, for newly developed methods and existing methods, in order to achieve predefined method performance throughout the method lifecycle and support green initiatives.
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