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液相色谱法分析卡格列净:简明综述与更绿色评价。

Liquid chromatographic methods for the analysis of canagliflozin: concise overview and greener assessment.

机构信息

Department of Pharmaceutical Chemistry, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110 062, India.

出版信息

Anal Methods. 2023 Sep 21;15(36):4627-4639. doi: 10.1039/d3ay00896g.

Abstract

There is a pressing need for the development of greener liquid chromatographic bioanalytical methods for antidiabetic drugs for plasma monitoring and revisiting patients' dosage regimens. Besides, analytical methods are also needed for the quality assurance of finished drug products and regulatory approval. Therefore, the present review focuses on the reported liquid chromatographic methods (LC and LC-MS/MS) that are applied for quality control, forced degradation, and pharmacokinetic studies of a newer antidiabetic agent, canagliflozin (CNG). These reported studies are summarized based on liquid chromatographic separation parameters, such as column dimensions, mobile-phase compositions, flow rate, and use of different detection systems (UV, PDA, and mass spectrometry). The sample pretreatment of biological fluids, which is important for minimizing the matrix effect, is dealt with separately. Liquid-liquid extraction was found to be the most preferred methodology adopted for sample pretreatment followed by the solid-phase extraction technique. However, miniaturized novel pretreatment methods are untraceable in the literature for the extraction of CNG. Special emphasis is paid to the assessment of the greenness profiles of the reported analytical methods for the consideration of sustainable development and green analytical chemistry. Based on the National Environmental Method Index (NEMI) assessment tool, most of the reported studies fulfilled around half of the parameters and were found to be about 50% greener. It is proposed that toxic or hazardous solvents, such as acetonitrile or methanol, should be replaced with greener and environmentally friendly solvents. Thus, there is a need to develop more robust, efficient, and greener liquid chromatographic methods for the determination of CNG in biological fluids and drug products.

摘要

目前迫切需要开发更绿色的用于监测血浆中抗糖尿病药物和重新调整患者剂量方案的液相色谱生物分析方法。此外,还需要分析方法来保证成品药物的质量和监管批准。因此,本综述重点介绍了用于质量控制、强制降解和药代动力学研究的新型抗糖尿病药物坎格列净(CNG)的已报道液相色谱方法(LC 和 LC-MS/MS)。这些已报道的研究根据液相色谱分离参数进行了总结,例如柱尺寸、流动相组成、流速以及不同检测系统(UV、PDA 和质谱)的使用。生物流体的样品预处理对于最小化基质效应非常重要,因此单独进行讨论。研究发现,液液萃取是最受欢迎的样品预处理方法,其次是固相萃取技术。然而,对于 CNG 的提取,文献中无法追踪到用于微型化新型预处理方法。特别强调了对已报道分析方法的绿色度进行评估,以考虑可持续发展和绿色分析化学。根据国家环境方法指数(NEMI)评估工具,大多数已报道的研究满足了约一半的参数,被认为具有约 50%的绿色度。因此,有必要开发更稳健、高效和更绿色的液相色谱方法,用于生物流体和药物产品中 CNG 的测定。

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