NMR Spectroscopy in Quality Analysis of drugs and Excipients – a holistic approach?

Ulrike Holzgrabe, Institute of Pharmacy, University of Wuerzburg, Wuerzburg, Germany (ulrike.holzgrabe@uni-wuerzburg.de)
Jonas Urlaub, Institute Of Pharmacy, University Of Wuerzburg, Wuerzburg, Germany
Elina Zailer, Spectralservice, Cologne, Germany
Yulia Monakhova, Spectralservice, Cologne, Germany
Bernd Diehl, Spectralservice, Cologne, Germany

In former time, NMR spectroscopy was mainly used for structure elucidation and confirmation of newly synthesized compounds as well as natural products. More recently, quantitative NMR spectroscopy was increasing reported as a valuable tool for pharmaceutical quality analysis. On the one hand, drugs and excipients can be identified by 1D and 2D NMR techniques and structurally similar compounds, being e.g. synthesis or degradation impurities, can be recognized. Furthermore, counterfeit drugs can easily be identified. On the other hand, NMR spectroscopy can quantitatively be used to determine the content of a drug, its related compounds, residual solvents and in some cases counterions. Since this can often be done in one run, NMR spectroscopy is able to outclass separation techniques such as HPLC and capillary electrophoresis with regard to time necessary for a measurement and structure information, which can simultaneously be retrieved. In the talk the requirement for qNMR as well as different techniques to be applied will explained and the applicability demonstrated by a number of pharmaceutical examples.

---

Abstract Reference & Short Personal Biography of Presenting Author

Prof. Dr. Ulrike Holzgrabe

received her diploma degree in Chemistry at the University of Marburg in 1979, her approbation in Pharmacy in 1982, and her PhD in Pharmaceutical Chemistry in 1983 both at the University of Kiel. After habilitation in Pharmaceutical Chemistry in Kiel 1989 she became an associate professor at the University of Bonn (1990-1999). In 1988 she was a post-doc fellow at the University of Bath, UK, with Alan Casy, in 1994 a visiting professor at the University of Erlangen with J. Gasteiger, and 1995 at the University of Illinois at Chicago with A.F. Hopfinger. Since 1999 she holds a full professorship at the University of Würzburg (declining offers from the universities of Tübingen, Münster and Berlin, and the CEO position of the BfArM). She served as vice-rector of the University of Bonn from 1997-1999, as a president of the German Pharmaceutical Society from 2004 till 2007 and as a vicepresident of the University Wuerzburg since 2018. She is a member of the German and European Committee of the Pharmacopoeia (BfArM, EDQM), and a member of the scientific boards of the BfArM, BPS of FIP, and the HIPS as well as a collegiate of the DFG. The research interests are the development of antiinfectives and GPCR ligands as well as quality analysis of drugs.