Analytical Sciences

Quality Control of Heparin Injections: Comparison of Four Established Methods

Natalia A. BURMISTROVA,*1 Bernd W. K. DIEHL,*2 Polina M. SOBOLEVA,*1 Ekaterina RUBTSOVA,*1,*3 Eugene A. LEGIN,*4 Andrey V. LEGIN,*4 Dmitry O. KIRSANOV,*4 and Yulia B. MONAKHOVA*1,*2

*1 Institute of Chemistry, Saratov State University, 83 Astrakhanskaya Street, Saratov 410012, Russia
*2 Spectral Service AG, Emil-Hoffmann-Straße 33, 50996 Köln, Germany
*3 Saratov State Medical University, Bolshaya Kazachia st., 112, Saratov 410012, Russia
*4 Institute of Chemistry, Saint Petersburg State University, 26 Universitetskii prospect, Petergof, St. Petersburg 198504, Russia

Heparin is an anticoagulant medication that is usually injected subcutaneously. The quality of a set of commercial heparin injections from different producers was examined by NMR, IR, UV-Vis spectroscopies and potentiometric multisensor system. The type of raw material regarding heparin animal origin and producer, heparin molecular weight and activity values were derived based on the non-targeted analysis of ¹H NMR fingerprints. DOSY NMR spectroscopy was additionally used to study homogeneity and additives profile. UV-Vis and IR, being cheaper than NMR, combined with multivariate statistics were successfully applied to study excipients composition as well as semi-estimation of activity values. Potentiometric multisensor measurements were found to be an important additional source of information about inorganic composition of finished heparin formulations. All investigated instrumental techniques are useful for finished heparin injections and should be selected according to availability as well as the information and confidence required for a specific sample.

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