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A simple capillary electrophoresis method for the rapid separation and determination of intact low molecular weight and unfractionated heparins

Citation

Patel, R and Narkowicz, CK and Hutchinson, J and Hilder, EF and Jacobson, GA, A simple capillary electrophoresis method for the rapid separation and determination of intact low molecular weight and unfractionated heparins, Journal of Pharmaceutical and Biomedical Analysis, 46, (1) pp. 30-35. ISSN 0731-7085 (2008) [Refereed Article]


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DOI: doi:10.1016/j.jpba.2007.10.009

Abstract

A simple, selective and accurate capillary electrophoresis (CE) method has been developed for the rapid separation and identification of various low molecular weight heparins (LMWHs) and unfractionated heparin. Separation and operational parameters were investigated using dalteparin sodium as the test LMWH. The developed method used a 70 cm fused silica capillary (50 ým i.d.) with a detection window 8.5 cm from the distal end. Phosphate electrolyte (pH 3.5; 50 mM), an applied voltage of −30 kV, UV detection at 230 nm and sample injection at 20 mbar for 5 s were used. The method performance was assessed in terms of linearity, selectivity, intra- and inter-day precision and accuracy. The method was successfully applied to the European Pharmacopeia LMWH standard, dalteparin sodium, enoxaparin sodium and heparin sodium with a significant reduction in the run time and increased resolution compared with previously reported CE methods. Different CE separation profiles were obtained for various LMWHs and unfractionated heparin showing significant structural diversity. The current methodology was sensitive enough to reveal minor constituent differences between two different batches of enoxaparin sodium. This CE method also clearly showed chemical changes that occurred to LMWHs under different stress conditions. The sensitivity, selectivity and simplicity of the developed method allow its application in research or manufacturing for the identification, stability analysis, characterization and monitoring of batch-to-batch consistency of different low molecular weight and unfractionated heparins.

Item Details

Item Type:Refereed Article
Keywords:low molecular weight heparin, dalteparin, heparin, capillary electrophoresis, batch-to-batch variations
Research Division:Medical and Health Sciences
Research Group:Pharmacology and Pharmaceutical Sciences
Research Field:Pharmaceutical Sciences
Objective Division:Health
Objective Group:Other Health
Objective Field:Health not elsewhere classified
Author:Patel, R (Dr Rahul Patel)
Author:Narkowicz, CK (Dr Christian Narkowicz)
Author:Hutchinson, J (Dr Joseph Hutchinson)
Author:Hilder, EF (Professor Emily Hilder)
Author:Jacobson, GA (Dr Glenn Jacobson)
ID Code:49466
Year Published:2008
Web of Science® Times Cited:44
Deposited By:Pharmacy
Deposited On:2007-08-01
Last Modified:2013-09-24
Downloads:1 View Download Statistics

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