X-ray Diffraction Analysis of Linezolid Crystalline Forms as Part of Quality Control

This work is a continuation of research on the use of X-ray diffraction analysis (XRD) for identification of medicines that exhibit polymorphism.The aim of the paper was to perform comparative XRD analysis of linezolid samples produced by different manufacturers.Materials and methods: the measuremen...

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Main Authors: V. S. Kuzmin, V. V. Chernyshev, A. I. Luttseva
Format: Article
Language:Russian
Published: NEICON ISP LLC 2019-12-01
Series:Ведомости Научного центра экспертизы средств медицинского применения
Subjects:
Online Access:https://www.vedomostincesmp.ru/jour/article/view/273
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author V. S. Kuzmin
V. V. Chernyshev
A. I. Luttseva
author_facet V. S. Kuzmin
V. V. Chernyshev
A. I. Luttseva
author_sort V. S. Kuzmin
collection DOAJ
description This work is a continuation of research on the use of X-ray diffraction analysis (XRD) for identification of medicines that exhibit polymorphism.The aim of the paper was to perform comparative XRD analysis of linezolid samples produced by different manufacturers.Materials and methods: the measurements were performed using an Empyrean X-ray powder diffraction system (PANalytical, Netherlands) with an X’Celerator linear solid-state detector using Ni-filtered CuKa radiation. The results were recorded at 1.5406 and 1.5444 А with the intensity ratio in the doublet of 2:1. The two-phase Rietveld refinement of the obtained diffractograms was used for the quantitative analysis.Results: the authors compared diffractograms of three commercial samples of linezolid. The revealed differences were analysed taking into consideration available literature on the polymorphic forms of linezolid. It was demonstrated that only forms II and IV should be considered as different polymorphs of linezolid.Conclusions: the study demonstrated that linezolid samples produced by different manufacturers could represent different polymorphs or mixtures thereof. The evaluation of linezolid quality by X-ray diffraction analysis requires the comparison of the obtained results with the diffractogram of the form IV reference standard. Relevant information should be provided by manufacturers in the product specification file.
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spelling doaj.art-2ddc4b690e55410187449cbb1f3283fb2024-04-21T11:46:33ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722019-12-019426126410.30895/1991-2919-2019-9-4-261-264220X-ray Diffraction Analysis of Linezolid Crystalline Forms as Part of Quality ControlV. S. Kuzmin0V. V. Chernyshev1A. I. Luttseva2Scientific Centre for Expert Evaluation of Medicinal ProductsM.V. Lomonosov Moscow State UniversityScientific Centre for Expert Evaluation of Medicinal ProductsThis work is a continuation of research on the use of X-ray diffraction analysis (XRD) for identification of medicines that exhibit polymorphism.The aim of the paper was to perform comparative XRD analysis of linezolid samples produced by different manufacturers.Materials and methods: the measurements were performed using an Empyrean X-ray powder diffraction system (PANalytical, Netherlands) with an X’Celerator linear solid-state detector using Ni-filtered CuKa radiation. The results were recorded at 1.5406 and 1.5444 А with the intensity ratio in the doublet of 2:1. The two-phase Rietveld refinement of the obtained diffractograms was used for the quantitative analysis.Results: the authors compared diffractograms of three commercial samples of linezolid. The revealed differences were analysed taking into consideration available literature on the polymorphic forms of linezolid. It was demonstrated that only forms II and IV should be considered as different polymorphs of linezolid.Conclusions: the study demonstrated that linezolid samples produced by different manufacturers could represent different polymorphs or mixtures thereof. The evaluation of linezolid quality by X-ray diffraction analysis requires the comparison of the obtained results with the diffractogram of the form IV reference standard. Relevant information should be provided by manufacturers in the product specification file.https://www.vedomostincesmp.ru/jour/article/view/273quality controlpolymorphismlinezolidx-ray diffraction analysisconformers
spellingShingle V. S. Kuzmin
V. V. Chernyshev
A. I. Luttseva
X-ray Diffraction Analysis of Linezolid Crystalline Forms as Part of Quality Control
Ведомости Научного центра экспертизы средств медицинского применения
quality control
polymorphism
linezolid
x-ray diffraction analysis
conformers
title X-ray Diffraction Analysis of Linezolid Crystalline Forms as Part of Quality Control
title_full X-ray Diffraction Analysis of Linezolid Crystalline Forms as Part of Quality Control
title_fullStr X-ray Diffraction Analysis of Linezolid Crystalline Forms as Part of Quality Control
title_full_unstemmed X-ray Diffraction Analysis of Linezolid Crystalline Forms as Part of Quality Control
title_short X-ray Diffraction Analysis of Linezolid Crystalline Forms as Part of Quality Control
title_sort x ray diffraction analysis of linezolid crystalline forms as part of quality control
topic quality control
polymorphism
linezolid
x-ray diffraction analysis
conformers
url https://www.vedomostincesmp.ru/jour/article/view/273
work_keys_str_mv AT vskuzmin xraydiffractionanalysisoflinezolidcrystallineformsaspartofqualitycontrol
AT vvchernyshev xraydiffractionanalysisoflinezolidcrystallineformsaspartofqualitycontrol
AT ailuttseva xraydiffractionanalysisoflinezolidcrystallineformsaspartofqualitycontrol