Quality control of pentosane polysulfate by capillary zone electrophoresis using indirect detection

Degenhardt, Matthias; Benend, Helmut; Wätzig, Hermann

doi:10.1016/s0021-9673(98)00421-x

Cited by 17 publications

(13 citation statements)

References 33 publications

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“…The minor differences between A, B, and C represent the inter-batch production variability. These differences are in the same range as differences between various raw material batches of NaPPS from one company [9] .…”

Section: Resultsmentioning

confidence: 74%

“…Conditioning times of 0.5, 2, 4, 6, and 10 h gave worse results. It was also important to use 1 M NaOH instead of the frequently used 0.1 M NaOH (compare [9][10][11][12] and Experimental).…”

Section: Resultsmentioning

confidence: 99%

“…Therefore it can be assumed that there are structural differences between the NaPPS synthesised in different factories but the extent of these differences could not be identified because of the limitations of traditional analytical techniques when applied to polysulfated polysaccharides. However, a high resolution capillary zone electrophoresis (CZE) method was recently developed to guarantee constant quality of pentosan polysulfate batches [9] . In the present study we used this same method to examine batches of three different manufacturers to compare the molecular characteristics of the NaPPS present within the respective formulations used for human and veterinary applications.…”

Section: Introductionmentioning

confidence: 99%

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Studies on the Structural Variations of Pentosan Polysulfate Sodium (NaPPS) from Different Sources by Capillary Electrophoresis

Degenhardt¹,

Ghosh²,

tzig³

2001

Arch. Pharm. Pharm. Med. Chem.

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Commercial pentosan polysulfate sodium salts (NaPPS) are highly sulfated polysaccharides derived from beechwood hemicellulose by sulfate esterification with a Mrel range of 1500—6000. The polysaccharide backbone of NaPPS consists of repeating linear units of 1—4 linked β‐D‐xylopyranose with laterally substituted 4‐methylglucopyranosyluronic acid units glycosidically linked to the 2 position of the main chain at every 10th xylopyranose unit on average. For many years NaPPS has been used for antithrombotic prophylaxis in Europe and interstitial cystitis in the USA and Australia. More recently NaPPS has found veterinary application for the treatment of osteoarthritis and related conditions in domestic animals and is registered for this use in Australia, New Zealand, Canada, UK, Eire, and several Scandanavian countries. At present the use of NaPPS for human disorders is confined to material manufactured by one company. However, for veterinary applications, NaPPS from three manufactures have been described. Since it is well known that the biological activities of sulfated polysaccharides are dependent on their molecular structures we considered it important to characterise these various NaPPS preparations using an established method of analysis. Unfortunately, traditional analytical techniques such as TLC, OR, UV/Vis spectroscopy, and size exclusion chromatography were incapable of providing structural information which would distinguish these NaPPS preparations from each other. In contrast, a capillary zone electrophoresis (CZE) method facilitated characterisation of the different NaPPS by a highly reproducible fingerprint, using a benzene‐1,2,4‐tricarboxylic acid buffer (8.75 mmol/L, pH = 4.9) with indirect UV detection (λ = 217 nm) and a special capillary pre‐treatment (1 M NaOH for 1 h at 25°C, then running buffer for 120 min at 25°C applying —20 kV). In the present study more than 20 batches of NaPPS from the three manufacturers have been investigated and compared. Minor batch variations were observed to exist for each manufacturer's product however significant differences were detected between NaPPS synthesised by the different manufacturers. Moreover, some preparations showed fingerprint profiles that indicated a more heterogeneous mixture, probably containing other polysaccharides as well.

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Section: Resultsmentioning

confidence: 74%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Studies on the Structural Variations of Pentosan Polysulfate Sodium (NaPPS) from Different Sources by Capillary Electrophoresis

Degenhardt¹,

Ghosh²,

tzig³

2001

Arch. Pharm. Pharm. Med. Chem.

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“…A suitable CE method for polysaccharides using indirect detection was performed by Degenhardt et al [12]. Capillary zone electrophoresis (CZE) analysis of the molecular mass distribution of PEGs has been successfully demonstrated by Sebastiano et al [13].…”

Section: Introductionmentioning

confidence: 99%

Analysis of the molecular size distribution of polyethylene glycols by CE‐UV versus HPLC with evaporative light scattering detection

Brinz

Holzgrabe

2008

Electrophoresis

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A simple capillary zone electrophoresis method has been developed for the separation of polyethylene glycols (PEGs) consisting of differing amounts of polymers with different monomer numbers up to an average molecular mass of 1500. To provide both charge and detectability, the analytes were derivatized with phthalic anhydride according to a conventional method and a newly developed microwave-assisted method. While obtaining nearly equal amounts of single and double esterificated PEGs with the conventional method, the fraction of single derivatized PEGs is considerably reduced by microwave-assisted reaction. In order to compare the capillary zone electrophoresis results, an HPLC method with evaporative light scattering detection has been established. This method was successfully applied to the analysis of underivatized PEG 400, 1000 and 1500.

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“…1), which has a D-gluconic acid at approximately every tenth unit. It is used for anticoagulant and anti-inflammatory treatments [1].…”

Section: Introductionmentioning

confidence: 99%

Improvements in pentosan polysulfate sodium quality assurance using fingerprint electropherograms

Schirm¹,

Benend

Wätzig

2001

Electrophoresis

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Complex samples from polymer production, plant extracts or biotechnology mixtures can be characterized by fingerprints. Currently, the standard approach for sample characterization employs near-infrared (NIR) spectroscopy fingerprinting. Up to now, however, fingerprints obtained by chromatography or electrophoresis could only be visually evaluated. This type of inspection is very labor-intensive and difficult to validate. In order to transfer the use of fingerprints from spectroscopy to electrophoresis, spectra-like properties must be obtained through a complete alignment of the electropherograms. This has been achieved by interpolation and wavelet filtering of the baseline signal in the present work. The resulting data have been classified by several algorithms. The methods under survey include self-organizing maps (SOMs), artificial neural networks (ANNs), soft independent modeling of class analogy (SIMCA) and k-nearest neighbors (KNNs). In order to test the performance of this combined approach in practice, it was applied to the quality assurance of pentosan polysulfate (PPS). A recently developed capillary electrophoresis (CE) method using indirect UV detection was employed in these studies [1]. All algorithms were well capable of classifying the examined PPS test batches. Even minor variations in the PPS composition, not perceptible by visual inspection, could be automatically detected. The whole method has been validated by classifying various (n = 400) unknown PPS quality assurance samples, which have been correctly identified without exception.

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Quality control of pentosane polysulfate by capillary zone electrophoresis using indirect detection

Cited by 17 publications

References 33 publications

Studies on the Structural Variations of Pentosan Polysulfate Sodium (NaPPS) from Different Sources by Capillary Electrophoresis

Studies on the Structural Variations of Pentosan Polysulfate Sodium (NaPPS) from Different Sources by Capillary Electrophoresis

Analysis of the molecular size distribution of polyethylene glycols by CE‐UV versus HPLC with evaporative light scattering detection

Improvements in pentosan polysulfate sodium quality assurance using fingerprint electropherograms

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