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磁共振波谱分析在定量分析中的应用:在化学、制药和医药领域的应用综述。

Nuclear Magnetic Resonance Spectroscopy for Quantitative Analysis: A Review for Its Application in the Chemical, Pharmaceutical and Medicinal Domains.

机构信息

Analytical Chemistry Section, Department of Chemistry, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

出版信息

Crit Rev Anal Chem. 2023;53(5):997-1011. doi: 10.1080/10408347.2021.2000359. Epub 2021 Nov 9.

Abstract

Nuclear magnetic resonance (NMR) is a rapid and accurate analytical tool for qualification and quantification. The capacity of NMR of being quantitative can also justify the calibration of other analytical methods. In pharmaceutical domain, quantitative NMR (qNMR) can be applied in the identification and quantification of drug simultaneously. The early drug development stage requires a minimum sample for analysis. Thus, priority should be given to utilize this technique to attain results with least investment, rapid analysis time and minimum sample consumption. This technique is a significant phenomenon to identify impurities, drug substance, residual solvents of in-process control (IPC) samples and characterizing the formulations. From an analyst's perspective, qNMR proved to be a routine practice in pharmaceutical industry to qualify any drug product. The absolute and relative methods offer great help in quantifying the component of interest in the process control samples and finished products. This review highlights the evolution of NMR application in the pharmaceutical industry, where determining the purity of drug substance, drug product and establishing the identity of impurities and its level are the challenging aspects. NMR in medicinal field emerging as a numero uno for Covid-19 severity detection and its dire consequences, accelerated vaccine development and the mapping of SAR-COV-2 RNA and proteins via chemical shift assignments.

摘要

核磁共振(NMR)是一种快速、准确的分析工具,可用于定性和定量分析。NMR 的定量能力也可以证明其他分析方法的校准是合理的。在制药领域,定量 NMR(qNMR)可用于同时鉴定和定量药物。在药物早期开发阶段,分析所需的样品量最少。因此,应优先利用该技术,以最少的投入、最快的分析时间和最少的样品消耗来获得结果。该技术是一种重要的现象,可以用于识别杂质、药物物质、过程控制(IPC)样品中的残留溶剂以及制剂的特性。从分析人员的角度来看,qNMR 已被证明是制药行业中对任何药物产品进行定性的常规实践。绝对和相对方法在过程控制样品和成品中定量测定感兴趣的成分方面提供了很大的帮助。本文综述了 NMR 在制药行业中的应用发展,其中药物物质、药物产品的纯度测定以及杂质的鉴定及其水平的确定是具有挑战性的方面。NMR 在医学领域的应用也崭露头角,可用于检测新冠病毒的严重程度及其严重后果,加速疫苗的开发,并通过化学位移分配来绘制 SAR-COV-2 RNA 和蛋白质图谱。

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