Spectral Service AG, Emil-Hoffmann-Str. 33, 50996, Cologne, Germany.
Institute of Pharmacy, University of Wuerzburg, Am Hubland, 97074, Wuerzburg, Germany.
J Pharm Biomed Anal. 2020 Jan 5;177:112847. doi: 10.1016/j.jpba.2019.112847. Epub 2019 Aug 30.
The quantification of a drug, its impurities, and e.g. components of a mixture has become routine in NMR laboratories and many applications have been described in the literature. However, besides simply using 1D H or C NMR, a number of more advanced methods has been developed and used in the past. Here, we want to describe the applicability of nuclei beyond the classical ones H and C. Mixtures can be characterized much better by applying various chemometric methods and separating the signals of mixture components can be achieved by DOSY experiments. All these methods contribute to the platform of qNMR methods and extend the possibilities of NMR for quantification and quality evaluation of drugs, excipients, polymers, and plant extracts. However, for quantification purposes, validation is always an issue and it is necessary to think about taking NMR related measures which might be different from the ones considered for chromatographic methods.
在 NMR 实验室中,药物、其杂质以及混合物的成分等的定量分析已经成为常规操作,并且在文献中有许多相关应用的描述。然而,除了简单地使用一维 H 或 C NMR 之外,过去还开发并使用了许多更先进的方法。在这里,我们希望描述除了经典的 H 和 C 核之外的核的适用性。通过应用各种化学计量学方法,可以更好地描述混合物的特征,并且可以通过 DOSY 实验实现混合物成分的信号分离。所有这些方法都为 qNMR 方法平台做出了贡献,并扩展了 NMR 在药物、赋形剂、聚合物和植物提取物的定量和质量评估方面的应用。然而,对于定量目的,验证始终是一个问题,有必要考虑采取与色谱方法不同的与 NMR 相关的措施。