Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals
Heparin is widely used as an anticoagulant for the treatment and prevention of various thrombotic diseases. However, due to its high anionic charge, heterogeneity in size distribution and high polarity, its analysis is very challenging. In this paper, a novel method based on size-exclusion chromatog...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Sciendo
2015-03-01
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| Series: | Acta Pharmaceutica |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/acph-2015-0010 |
| _version_ | 1819121832619409408 |
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| author | Matanović Maja Radivojša Grabnarm Iztok Grabnar Pegi Ahlin Roškar Robert |
| author_facet | Matanović Maja Radivojša Grabnarm Iztok Grabnar Pegi Ahlin Roškar Robert |
| author_sort | Matanović Maja Radivojša |
| collection | DOAJ |
| description | Heparin is widely used as an anticoagulant for the treatment and prevention of various thrombotic diseases. However, due to its high anionic charge, heterogeneity in size distribution and high polarity, its analysis is very challenging. In this paper, a novel method based on size-exclusion chromatography (SEC) for quantitative determination of intact heparin in pharmaceuticals is presented. Analyses were performed on a BioSep-SEC-S 2000 column with Larginine solution at pH 6.5 as mobile phase and UV detection at 210 nm. The proposed method was found to be selective, linear (R2 > 0.997) over the concentration range of 3.1 to 1222 μg mL-1, with a limit of detection of 1.0 μg mL-1. Intraday and inter-day precision were below 5.1 % and inaccuracy expressed as bias did not exceed 6.5 %. The reported method is simple, selective, sensitive, and requires no laborious sample preparation, which makes it appropriate for routine quantitative analysis of heparin in pharmaceuticals |
| first_indexed | 2024-12-22T06:42:50Z |
| format | Article |
| id | doaj.art-8ca89195e8e74583b153631fdfb2885c |
| institution | Directory Open Access Journal |
| issn | 1846-9558 |
| language | English |
| last_indexed | 2024-12-22T06:42:50Z |
| publishDate | 2015-03-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj.art-8ca89195e8e74583b153631fdfb2885c2022-12-21T18:35:24ZengSciendoActa Pharmaceutica1846-95582015-03-01651435210.1515/acph-2015-0010acph-2015-0010Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticalsMatanović Maja Radivojša0Grabnarm Iztok1Grabnar Pegi Ahlin2Roškar Robert3Faculty of Pharmacy University of Ljubljana 1000 Ljubljana, SloveniaFaculty of Pharmacy University of Ljubljana 1000 Ljubljana, SloveniaFaculty of Pharmacy University of Ljubljana 1000 Ljubljana, SloveniaFaculty of Pharmacy University of Ljubljana 1000 Ljubljana, SloveniaHeparin is widely used as an anticoagulant for the treatment and prevention of various thrombotic diseases. However, due to its high anionic charge, heterogeneity in size distribution and high polarity, its analysis is very challenging. In this paper, a novel method based on size-exclusion chromatography (SEC) for quantitative determination of intact heparin in pharmaceuticals is presented. Analyses were performed on a BioSep-SEC-S 2000 column with Larginine solution at pH 6.5 as mobile phase and UV detection at 210 nm. The proposed method was found to be selective, linear (R2 > 0.997) over the concentration range of 3.1 to 1222 μg mL-1, with a limit of detection of 1.0 μg mL-1. Intraday and inter-day precision were below 5.1 % and inaccuracy expressed as bias did not exceed 6.5 %. The reported method is simple, selective, sensitive, and requires no laborious sample preparation, which makes it appropriate for routine quantitative analysis of heparin in pharmaceuticalshttps://doi.org/10.1515/acph-2015-0010heparinquantitative analysissize-exclusion chromatographyl-arginine |
| spellingShingle | Matanović Maja Radivojša Grabnarm Iztok Grabnar Pegi Ahlin Roškar Robert Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals Acta Pharmaceutica heparin quantitative analysis size-exclusion chromatography l-arginine |
| title | Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals |
| title_full | Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals |
| title_fullStr | Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals |
| title_full_unstemmed | Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals |
| title_short | Development and validation of a simple and sensitive size-exclusion chromatography method for quantitative determination of heparin in pharmaceuticals |
| title_sort | development and validation of a simple and sensitive size exclusion chromatography method for quantitative determination of heparin in pharmaceuticals |
| topic | heparin quantitative analysis size-exclusion chromatography l-arginine |
| url | https://doi.org/10.1515/acph-2015-0010 |
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