Department of Quality Assurance, Maliba Pharmacy College, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat 394 350 Gujarat, India.
Ohio University, Department of Chemistry and Biochemistry, Athens, OH 45701, USA.
J Chromatogr Sci. 2024 Aug 20;62(7):649-659. doi: 10.1093/chromsci/bmad033.
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.
阿哌沙班（APX）是一种新型抗凝药物，已获美国食品药品监督管理局（USFDA）批准。根据相关文献，已经发表了许多色谱方法，如反相高效液相色谱法（RP-HPLC）和高效薄层色谱法（HPTLC），用于 APX 的稳定性研究。但这些色谱方法是使用有毒有机溶剂开发的，对环境有危害，对分析人员也不安全。因此，为了分析师的安全和环境的保护，已经开发了基于绿色和可持续分析化学的色谱方法，使用安全的有机溶剂用于 APX 的稳定性研究。APX 进行了强制降解，以开发用于稳定性指示的分析方法。该方法的开发通过实施化学计量学和设计实验（DoE）方法，以最小化溶剂浪费。主成分分析（PCA）用于识别关键方法风险变量（MRVs）和方法性能属性。基于设计实验的响应面建模用于优化关键 MRVs。通过 NEMI 和 AGREE 方法评估已发表和开发的色谱方法的绿色性概况，以评估 APX。与已发表的色谱方法相比，所开发的方法在用于 APX 的估计时更具环保性和稳健性。
