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Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals Cover

Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals

Acta Pharmaceutica
Volume 65 (2015): Issue 1 (March 2015)
By: Maja Radivojša Matanović,  Iztok Grabnarm,  Pegi Ahlin Grabnar and  Robert Roškar  
Open Access
|Mar 2015

References

  1. 1. J. Hirsh, Heparin, N. Engl. J. Med. 324 (1991) 1565-1574; DOI: 10.1056/NEJM199111283252213.10.1056/NEJM1991112832522131944445
    Search in Google Scholar
  2. 2. J. Hirsh, T. E. Warkentin, S. G. Ghaughnessy, S. S. Anand, J. L. Halperin, R. Raschke, C. Granger, E. Magnus Ohman and J. E. Dalen, Heparin and low-molecular-weight heparin mechanisms of action, Pharmacokinetics, dosing, monitoring, efficacy, and safety, Chest 119 (2001) 64S-94S; DOI: 10.1378/chest.119.1_suppl.64S.10.1378/chest.119.1_suppl.64S11157643
    Search in Google Scholar
  3. 3. A. B. Blann, M. J. Landray and G. Y. H. Lip, ABC of antithrombotic therapy: An overview of antithrombotic therapy, B.M.J 325 (2002) 762-765; DOI: 10.1136/bmj.325.7367.762.10.1136/bmj.325.7367.762112427612364307
    Search in Google Scholar
  4. 4. J. Hirsh, A. K. Bauer, M. B. Donati, M. Gould, M. M. Samama and J. I. Weitz, Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Ed.), Chest 133 (2008) 141S-159S; DOI: 10.1378/chest.08-0689.10.1378/chest.08-068918574264
    Search in Google Scholar
  5. 5. J. Hirsh, T. E. Warkentin, R. Raschke, C. Granger, E. Magnus Ohman and J. E. Dalen, Heparin and low-molecular-weight heparin mechanisms of action, pharmacokinetics, dosing, considerations, monitoring, efficacy, and safety, Chest 114 (1998) 489S-510S; DOI: 10.1378/chest.114.5_ Supplement.489S.
    Search in Google Scholar
  6. 6. A. Ziegler and J. Zaia, Size-exclusion chromatography of heparin oligosaccharides at high and low pressure, J. Chromatogr. B 837 (2006) 76-86; DOI: 10.1016/j.jchromb.2006.04.013.10.1016/j.jchromb.2006.04.01316704936
    Search in Google Scholar
  7. 7. S. Beni, J. F. K. Limtiaco and C. K. Larive, Analysis and characterization of heparin impurities, Anal. Bioanal. Chem. 399 (2011) 527-539; DOI: 10.1007/s00216-010-4121-x.10.1007/s00216-010-4121-x301516920814668
    Search in Google Scholar
  8. 8. D. S. Weitz and J. I. Weitz, Update on heparin: what do we need to know?, J. Thromb. Thrombolysis 29 (2010) 199-207; DOI: 10.1007/s11239-009-0411-6.10.1007/s11239-009-0411-619882363
    Search in Google Scholar
  9. 9. A. K. Korir and C. K. Larive, Advances in the separation, sensitive detection, and characterization of heparin and heparan sulfate, Anal. Bioanal. Chem. 393 (2009) 155-169; DOI: 10.1007/s00216-008-2412-2.10.1007/s00216-008-2412-218841350
    Search in Google Scholar
  10. 10. W. Mao, C. Thanawiroon and R. J. Linhardt, Capillary electrophoresis for the analysis of glycosaminoglycans and glycosaminoglycan-derived oligosaccharides, Biomed. Chromatogr. 16 (2002) 77-94; DOI: 10.1002/bmc.153.10.1002/bmc.15311857641
    Search in Google Scholar
  11. 11. J. Beirne, H. Truchan and L. Rao, Development and qualifi cation of a size exclusion chromatography coupled with multiangle light sca_ ering method for molecular weight determination of unfractionated heparin, Anal. Bioanal. Chem. 399 (2011) 717-725; DOI: 10.1007/s00216-010-4187-5.10.1007/s00216-010-4187-520838778
    Search in Google Scholar
  12. 12. F. Zhang, B. Yang, M. Ly, K. Solakyildirim, Z. Xiao, Z. Wang, J. M. Beaudet, A. Y. Torelli, J. S. Dordick and R. J. Linhardt, Structural characterization of heparins from diff erent commercial sources, Anal. Bioanal. Chem. 401 (2011) 2793-2803; DOI: 10.1007/s00216-011-5367-7. 13. J. E. Knobloch and P. N. Shaklee, Absolute molecular weight distribution of low-molecular-weight heparins by size-exclusion chromatography with multiangle laser light sca_ ering detection, Anal. Biochem. 245 (1997) 231-241; DOI: 10.1006/abio.1996.9984.10.1006/abio.1996.9984
    Search in Google Scholar
  13. 14. X. Guo, M. Condra, K. Kimura, G. Berth, H. Dautzenberg and P. L. Dubin, Determination of molecular weight of heparin by size exclusion chromatography with universal calibration, Anal. Biochem. 312 (2003) 33-39; DOI: 10.1016/S0003-2697(02)00428-1.10.1016/S0003-2697(02)00428-1
    Search in Google Scholar
  14. 15. S. Bertini, A. Bisio, G. Torri, D. Bensi and M. Terbojevich, Molecular weight determination of heparin and dermatan sulfate by size exclusion chromatography with a triple detector array, Biomacromolecules 6 (2005) 168-173; DOI: 10.1021/bm049693s.10.1021/bm049693s
    Search in Google Scholar
  15. 16. O. F. Swoap and M. H. Kuizenga, The sheep plasma method for the bioassay of heparin preparations, J. Am. Pharm. Assoc. 38 (1949) 563-565; DOI: 10.1002/jps.3030381012.10.1002/jps.3030381012
    Search in Google Scholar
  16. 17. C. D. Sommers, N. Montpas, A. Adam and D. A. Keire, Characterization of currently marketed heparin products: adverse event relevant bioassays, J. Pharm. Biomed. Anal. 67-68 (2012) 28-35; DOI: 10.1016/j.jpba.2012.04.017.10.1016/j.jpba.2012.04.017
    Search in Google Scholar
  17. 18. European Pharmacopoeia, 8th ed., Vol. 2, Council of Europe, Strasbourg 2013, pp. 2390-2391.
    Search in Google Scholar
  18. 19. United States Pharmacopoeia 36, National Formulary 31, Vol. 2, USP Convention, Rockville 2013, pp. 3801-3805.
    Search in Google Scholar
  19. 20. P. K. Smith, A. K. Mallia and G. T. Hermanson, Colorimetric method for the assay of heparin content in immobilized heparin preparations, Anal. Biochem. 109 (1980) 466-473; DOI: 10.1016/0003-2697(80)90679-X.10.1016/0003-2697(80)90679-X
    Search in Google Scholar
  20. 21. I. Nemcova, P. Rychlovsky, M. Havelcova and M. Brabcova, Determination of heparin using flow injection analysis with spectrophotometric detection, Anal. Chim. Acta 401 (1999) 223-228; DOI: 10.1016/S0003-2670(99)00472-9.10.1016/S0003-2670(99)00472-9
    Search in Google Scholar
  21. 22. A. Karewicz, K. Zasada, K. Szczubialka, S. Zapotoczny, R. Lach and M. Nowakowska, “Smart” alginate-hydroxypropylcellulose microbeads for controlled release of heparin, Int. J. Pharm. 385 (2010) 163-169; DOI: 10.1016/j.ij pharm.2009.10.021.
    Search in Google Scholar
  22. 23. C. E. Doneanu and W. Chen, Impurity evaluation of heparin sodium by anion exchange chromatography, Waters Application Note, Milford (MA) 2009.
    Search in Google Scholar
  23. 24. X. Xu, Y. Li, A. Cui and H. Chen, High Resolution Analysis of Heparin and Heparin-like Impurities on GlycomixTM - an Anion Exchange Column. Glycan separation, Sepax Application Note, Sepax Technologies, Delaware 2012.
    Search in Google Scholar
  24. 25. M. L. Trehy, J. C. Reepmeyer, R. E. Kolinski, B. J. Westenberger and L. F. Buhse, Analysis of heparin sodium by SAX/HPLC for contaminants and impurities, J. Pharm. Biomed. Anal. 49 (2009) 670-673; DOI: 10.1016/j.jpba.2008.12.013.10.1016/j.jpba.2008.12.01319167854
    Search in Google Scholar
  25. 26. D. A. Keire, M. L. Trehy, J. C. Reepmeyer, R. E. Kolinski, W. Ye, J. Dunn, B. J. Westenberger and L. F. Buhse, Analysis of crude heparin by 1H NMR, capillary electrophoresis, and strong-anion-exchange- HPLC for contamination by over sulfated chondroitin sulfate, J. Pharm. Biomed. Anal. 51 (2010) 921-926; DOI: 10.1016/j.jpba.2009.10.017.10.1016/j.jpba.2009.10.01719959313
    Search in Google Scholar
  26. 27. D. A. Keire, D. J. Mans, H. Ye, R. E. Kolinski and L. F. Buhse, Assay of possible economically motivated additives or native impurities levels in heparin by 1H NMR, SAX-HPLC, and anticoagulation time approaches, J. Pharm. Biomed. Anal. 52 (2010) 656-664; DOI: 10.1016/j.jpba.2010.02.019.10.1016/j.jpba.2010.02.01920233649
    Search in Google Scholar
  27. 28. M. Radivojša, I. Grabnar and P. Ahlin Grabnar, Thermoreversible in situ gelling poloxamer-based systems with chitosan nanocomplexes for prolonged subcutaneous delivery of heparin: Design and in vitro evaluation, Eur. J. Pharm. Sci. 50 (2013) 93-101; DOI: 10.1016/j.ejps.2013.03.002.10.1016/j.ejps.2013.03.00223524253
    Search in Google Scholar
  28. 29. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version, Geneva, November 2005.
    Search in Google Scholar
  29. 30. Q. Jiao and Q. Liu, Mechanism of interference and Azur A response in the heparin assay, Anal. Le . 31 (1998) 1311-1323; DOI: 10.1080/00032719808002868. 10.1080/00032719808002868
    Search in Google Scholar
DOI: https://doi.org/10.1515/acph-2015-0010 | Journal eISSN: 1846-9558 | Journal ISSN: 1330-0075
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Language: English
Page range: 43 - 52
Submitted on: Oct 23, 2014
Published on: Mar 11, 2015
Published by: Croatian Pharmaceutical Society
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
Keywords:
heparin,
quantitative analysis,
size-exclusion chromatography,
L-arginine
Related subjects:
Pharmacy,
Pharmacy, other

© 2015 Maja Radivojša Matanović, Iztok Grabnarm, Pegi Ahlin Grabnar, Robert Roškar, published by Croatian Pharmaceutical Society
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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