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

被引:6
作者
Prajapati, Pintu [1 ]
Rajpurohit, Pooja [1 ]
Pulusu, Veera Shakar [2 ]
Shah, Shailesh [1 ]
机构
[1] Maliba Pharm Coll, Dept Qual Assurance, Maliba Campus,Bardoli Mahuva Rd, Surat 394350, Gujarat, India
[2] Ohio Univ, Dept Chem & Biochem, Athens, OH 45701 USA
关键词
apixaban; green and sustainable analytical chemistry; principal component analysis; design of experiments; high-performance thin-layer chromatography; ENHANCED ANALYTICAL QUALITY; DOSE COMBINATION PRODUCTS; RP-HPLC METHOD; DMAIC PRINCIPLE; SYNCHRONOUS ESTIMATION; DOE; RISK; IMPLEMENTATION;
D O I
10.1093/chromsci/bmad033
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
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.
引用
收藏
页码:649 / 659
页数:11
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