Green and Sustainable Analytical Chemistry-Driven Chromatographic Method Development for Stability Study of Apixaban Using Box-Behnken Design and Principal Component Analysis.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS Journal of chromatographic science Pub Date : 2024-08-20 DOI:10.1093/chromsci/bmad033

Pintu Prajapati, Pooja Rajpurohit, Veera Shakar Pulusu, Shailesh Shah

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Abstract

Apixaban (APX) is a novel anti-coagulant drug approved by USFDA. According to referred literature, numerous chromatographic methods such as RP-HPLC and high-performance thin-layer chromatography have been published for the stability study of APX. But these chromatographic methods have been developed using toxic organic solvents that are hazardous to the environment and unsafe for analysts. Hence, green and sustainable analytical chemistry-driven chromatographic method has been developed for the stability study of APX using safe organic solvents for the safety of analysts and the protection of the environment. APX was subjected to forced degradation for the development of a stability-indicating assay method. The method development was carried out by the implementation of chemometric and DoE approaches for minimizing solvent wastage. Principal component analysis was applied for the identification of critical method risk variables (MRVs) and method performance attributes. DoE-based response surface modelling was applied for the optimisation of critical MRVs. The greenness profile scales of published and developed chromatographic methods have been assessed by NEMI and AGREE methods for the estimation of APX. The developed method was found to be more eco-friendly and robust than the published chromatographic methods for the estimation of APX.

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利用盒-贝肯设计和主成分分析法，为阿哌沙班的稳定性研究开发绿色和可持续的分析化学驱动色谱方法

阿哌沙班（APX）是美国食品药品管理局批准的一种新型抗凝血药物。根据参考文献，已有许多色谱法（如 RP-HPLC 和高效薄层色谱法）用于 APX 的稳定性研究。但这些色谱法都是使用对环境有害且对分析人员不安全的有毒有机溶剂开发的。因此，为了分析人员的安全和保护环境，我们使用安全的有机溶剂开发了绿色、可持续的分析化学驱动色谱法，用于 APX 的稳定性研究。对 APX 进行强制降解以建立稳定性指示检测方法。该方法的开发采用了化学计量学和 DoE 方法，以尽量减少溶剂的浪费。主成分分析用于识别关键方法风险变量（MRV）和方法性能属性。基于 DoE 的响应面建模被用于优化关键 MRV。采用 NEMI 和 AGREE 方法评估了已发布和已开发色谱方法的绿色度曲线尺度，以估算 APX。结果表明，在估算 APX 时，所开发的方法比已公布的色谱法更环保、更稳健。

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来源期刊

Journal of chromatographic science 化学-分析化学

CiteScore

2.90

自引率

7.70%

发文量

审稿时长

5.6 months

期刊介绍： The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.