Quantitative NMR spectroscopy in pharmaceutical applications

摘要

The role of Quantitative NMR (qNMR) spectroscopy in pharmaceutical applications are discussed. qNMR is linear over a wide concentration range and it seems to be more robust than the separation methods coupled to UV, fluorescence, CAD, NQAD, and ELSD. It requires minimal sample preparation and a readily available internal standard (IS). Simultaneous determination of content, detection of impurities, residual solvents and other additives is possible as long as a component contains the nucleus observed. While the pharmaceutical companies extensively apply qNMR in drug discovery and development they mostly use HPLC in routine quality analysis rather than qNMR. Recently, qNMR became the leading method for the purity analysis of unfractionated heparin sodium and calcium in the USP which was deliberately contaminated with anaphylactoid oversulfated chondroitin sulphate (OSCS). qNMR should be considered more often for quantification and quality control of drugs, excipients, agrochemicals, and food ingredients.