Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS

The identification of new contaminants is critical in the development of new medicinal products. Many impurities, such as pentanedioic acid, hexanedioic acid, heptanedioic acid, octanedioic acid, decanedioic acid, undecanedioic acid, dodecanedioic acid, tridecanedioic acid, and tetradecanedioic acid...

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Main Authors:	Han, Stanisław, Karłowicz-Bodalska, Katarzyna, Potaczek, Piotr, Wójcik, Adam, Ozimek, Łukasz, Szura, Dorota, Musiał, Witold
Format:	Online
Language:	English
Published:	Springer US 2013
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3909152/

id	pubmed-3909152
recordtype	oai_dc
spelling	pubmed-39091522014-02-05 Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS Han, Stanisław Karłowicz-Bodalska, Katarzyna Potaczek, Piotr Wójcik, Adam Ozimek, Łukasz Szura, Dorota Musiał, Witold Research Article The identification of new contaminants is critical in the development of new medicinal products. Many impurities, such as pentanedioic acid, hexanedioic acid, heptanedioic acid, octanedioic acid, decanedioic acid, undecanedioic acid, dodecanedioic acid, tridecanedioic acid, and tetradecanedioic acid, have been identified in samples of azelaic acid. The aim of this study was to identify impurities observed during the stability tests of a new liposomal dosage form of azelaic acid that is composed of phosphatidylcholine and a mixture of ethyl alcohol and water, using high-performance liquid chromatography with evaporative light-scattering detector (HPLC-ELSD), gas chromatography–flame ionisation detection (GC-FID), and gas chromatography–mass spectrometry (GC-MS) methods. During the research and development of a new liposomal formulation of azelaic acid, we developed a method for determining the contamination of azelaic acid using HPLC-ELSD. During our analytical tests, we identified a previously unknown impurity of a liposomal preparation of azelaic acid that appeared in the liposomal formulation of azelaic acid during preliminary stability studies. The procedure led to the conclusion that the impurity was caused by the reaction of azelaic acid with one of the excipients that was applied in the product. The impurity was finally identified as an ethyl monoester of azelaic acid. The identification procedure of this compound was carried out in a series of experiments comparing the chromatograms that were obtained via the following chromatographic methods: HPLC-ELSD, GC-FID, and GC-MS. The final identification of the compound was carried out by GC with MS. Springer US 2013-10-29 /pmc/articles/PMC3909152/ /pubmed/24166667 http://dx.doi.org/10.1208/s12249-013-0038-y Text en © The Author(s) 2013 Open Access This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	Han, Stanisław Karłowicz-Bodalska, Katarzyna Potaczek, Piotr Wójcik, Adam Ozimek, Łukasz Szura, Dorota Musiał, Witold
spellingShingle	Han, Stanisław Karłowicz-Bodalska, Katarzyna Potaczek, Piotr Wójcik, Adam Ozimek, Łukasz Szura, Dorota Musiał, Witold Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS
author_facet	Han, Stanisław Karłowicz-Bodalska, Katarzyna Potaczek, Piotr Wójcik, Adam Ozimek, Łukasz Szura, Dorota Musiał, Witold
author_sort	Han, Stanisław
title	Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS
title_short	Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS
title_full	Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS
title_fullStr	Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS
title_full_unstemmed	Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS
title_sort	identification of unknown impurity of azelaic acid in liposomal formulation assessed by hplc-elsd, gc-fid, and gc-ms
description	The identification of new contaminants is critical in the development of new medicinal products. Many impurities, such as pentanedioic acid, hexanedioic acid, heptanedioic acid, octanedioic acid, decanedioic acid, undecanedioic acid, dodecanedioic acid, tridecanedioic acid, and tetradecanedioic acid, have been identified in samples of azelaic acid. The aim of this study was to identify impurities observed during the stability tests of a new liposomal dosage form of azelaic acid that is composed of phosphatidylcholine and a mixture of ethyl alcohol and water, using high-performance liquid chromatography with evaporative light-scattering detector (HPLC-ELSD), gas chromatography–flame ionisation detection (GC-FID), and gas chromatography–mass spectrometry (GC-MS) methods. During the research and development of a new liposomal formulation of azelaic acid, we developed a method for determining the contamination of azelaic acid using HPLC-ELSD. During our analytical tests, we identified a previously unknown impurity of a liposomal preparation of azelaic acid that appeared in the liposomal formulation of azelaic acid during preliminary stability studies. The procedure led to the conclusion that the impurity was caused by the reaction of azelaic acid with one of the excipients that was applied in the product. The impurity was finally identified as an ethyl monoester of azelaic acid. The identification procedure of this compound was carried out in a series of experiments comparing the chromatograms that were obtained via the following chromatographic methods: HPLC-ELSD, GC-FID, and GC-MS. The final identification of the compound was carried out by GC with MS.
publisher	Springer US
publishDate	2013
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3909152/
_version_	1612053518531690496

Identification of Unknown Impurity of Azelaic Acid in Liposomal Formulation Assessed by HPLC-ELSD, GC-FID, and GC-MS

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