Quality Control of Heparin Injections: Comparison of Four Established Methods

被引：9

作者：

Burmistrova, Natalia A. ^{[1
]}

Diehl, Bernd W. K. ^{[2
]}

Soboleva, Polina M. ^{[1
]}

Rubtsova, Ekaterina ^{[1
,3
]}

Legin, Eugene A. ^{[4
]}

Legin, Andrey, V ^{[4
]}

Kirsanov, Dmitry O. ^{[4
]}

Monakhova, Yulia B. ^{[1
,2
]}

机构：

[1] Saratov NG Chernyshevskii State Univ, Inst Chem, 83 Astrakhanskaya St, Saratov 410012, Russia

[2] Spectral Serv AG, Emil Hoffmann Str 33, D-50996 Cologne, Germany

[3] Saratov State Med Univ, Bolshaya Kazachia St 112, Saratov 410012, Russia

[4] St Petersburg State Univ, Inst Chem, 26 Univ Skii Prospect, St Petersburg 198504, Russia

来源：

ANALYTICAL SCIENCES | 2020年 / 36卷 / 12期

基金：

俄罗斯科学基金会;

关键词：

Spectroscopy; sensors; heparin; injections; principal component analysis; MOLECULAR-WEIGHT; ELECTRONIC TONGUE; DERMATAN SULFATE; SPECTROSCOPY; NMR; GLYCOSAMINOGLYCANS; PHARMACEUTICALS; COMPLEX; PORCINE; EXAMPLE;

D O I：

10.2116/analsci.20P214

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

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 H-1 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.

引用

页码：1467 / 1472

页数：6

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