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Journal of Research in Physics

The Journal of University of Novi Sad

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2217-933X
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X-ray diffraction characterization of different polymorphyc forms of clopidogrel bisulphate in substance and pharmaceutical dosage form

Olivera R. Klisurića
  • Corresponding author
  • University of Novi Sad. Faculty of Sciences. Department of Physics, Trg Dositeja Obradovica 4, 21000 Novi Sad. Serbia
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/ Srđan J. Rakića
  • University of Novi Sad. Faculty of Sciences. Department of Physics, Trg Dositeja Obradovica 4, 21000 Novi Sad. Serbia
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/ Miroslav J. Cvetinov
  • University of Novi Sad. Faculty of Sciences. Department of Physics, Trg Dositeja Obradovica 4, 21000 Novi Sad. Serbia
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/ Maja M. Stojanović
  • University of Novi Sad. Faculty of Sciences. Department of Physics, Trg Dositeja Obradovica 4, 21000 Novi Sad. Serbia
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/ Andrea R. Nikolić
  • University of Novi Sad. Faculty of Sciences. Department of Chemistry. Biochemistry and Environmental Protection, Trg Dositeja Obradovica 3, 21000 Novi Sad. Serbia
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/ Suzana S. Jovanović Santa
  • University of Novi Sad. Faculty of Sciences. Department of Chemistry. Biochemistry and Environmental Protection, Trg Dositeja Obradovica 3, 21000 Novi Sad. Serbia
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/ Ana R. Marković / Ljiljana N. Solomun
Published Online: 2014-05-27 | DOI: https://doi.org/10.2478/jrp-2013-0006

Abstract

The present study deals with the application of X-ray powder diffraction (XRPD) analysis as a technique for identification of the forms of clopidogrel bisulphate (CLP) present in both the active pharmaceutical ingredients (API) and tablets, specifically addressing the question of whether API converts to another form after 12 months of storage. The investigation of the possibility of phase transitions occurring over a temperature range spanning from room temperature to the melting point, both in tablets and pure CLP, were also performed. Tablet samples were observed for the changes in their structure using polarizing optical microscopy, which was also used to determine the melting points of tablet samples. The results gained during this work confirm that XRPD is applicable for API and tablets testing. This is particularly important if we take into account that the method can be used during stability studies, i.e. in order to test the quality of tablets during the validity period.

Keywords: Drug polymorphs; clopidogrel bisulphate; X-ray powder diffraction analysis; polarizing optical microscopy

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About the article

Received: 2014-01-15

Published Online: 2014-05-27

Published in Print: 2013-01-01


Citation Information: Journal of Research in Physics, ISSN (Online) 2217-933X, DOI: https://doi.org/10.2478/jrp-2013-0006.

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© by Olivera R. Klisurića. This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. BY-NC-ND 3.0

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