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制药领域手性分子对映体识别与拆分技术的最新进展

Recent Advances in Enantiorecognition and Enantioseparation Techniques of Chiral Molecules in the Pharmaceutical Field.

作者信息

Barman Kuladip, Islam Md Mustahidul, Das Km Supriya, Singh Neha, Priya Sakshi, Kurmi Balak Das, Patel Preeti

机构信息

Department of Pharmaceutical Chemistry and Analysis, ISF College of Pharmacy, Moga, Punjab, India.

Department of Pharmaceutics, ISF College of Pharmacy, Moga, Punjab, India.

出版信息

Biomed Chromatogr. 2025 Feb;39(2):e6073. doi: 10.1002/bmc.6073.

Abstract

Enantioseparation and enantiorecognition are crucial in the pharmaceutical analysis of chiral substances, impacting safety, efficacy, and regulatory compliance. Enantioseparation refers to the process of separating enantiomers from a mixture, typically achieved through chromatography techniques like HPLC and SFC. In contrast, enantiorecognition involves the identification of enantiomers based on their interaction with a chiral selector without the need for separation. Recent advancements in these techniques have significantly improved enantioseparation efficiency and resolution. Chiral stationary phases (CSPs) have evolved, offering better selectivity, including hybrid organic-inorganic materials and miniaturization. The use of green solvents has also reduced environmental impact. Non-chromatographic methods, such as circular dichroism (CD) and nuclear magnetic resonance (NMR) spectroscopy, enable enantiorecognition through interactions with polarized light or chiral solvents. However, these methods face challenges, including high costs, limited solvent compatibility, and shorter operational lifespans compared with chromatographic techniques. Recent developments in solvent-tolerant hybrid CSPs aim to address these limitations. This review highlights these innovations, focusing on their relevance to the pharmaceutical industry, pollution control, and quality assurance, and emphasizes the growing importance of these techniques in the production and regulation of chiral drugs.

摘要

对映体拆分和对映体识别在手性物质的药物分析中至关重要,影响着安全性、有效性和法规遵从性。对映体拆分是指从混合物中分离对映体的过程,通常通过高效液相色谱(HPLC)和超临界流体色谱(SFC)等色谱技术来实现。相比之下,对映体识别涉及基于对映体与手性选择剂的相互作用来识别对映体,而无需进行分离。这些技术的最新进展显著提高了对映体拆分效率和分离度。手性固定相(CSP)不断发展,提供了更好的选择性,包括有机-无机杂化材料和小型化。绿色溶剂的使用也减少了对环境的影响。非色谱方法,如圆二色光谱(CD)和核磁共振(NMR)光谱,通过与偏振光或手性溶剂的相互作用实现对映体识别。然而,这些方法面临着挑战,包括成本高、溶剂兼容性有限以及与色谱技术相比使用寿命较短。耐溶剂杂化CSP的最新进展旨在解决这些局限性。本综述突出了这些创新,重点关注它们与制药行业、污染控制和质量保证的相关性,并强调了这些技术在生产和监管手性药物方面日益重要的地位。

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