Quantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation

Heat sterilization of glucose solutions can lead to the formation of various glucose degradation products (GDPs) due to oxidation, hydrolysis, and dehydration. GDPs can have toxic effects after parenteral administration due to their high reactivity. In this study, the application of the F0 concept t...

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Autores principales:	Sarah Leitzen, Matthias Vogel, Michael Steffens, Thomas Zapf, Christa Elisabeth Müller, Martin Brandl
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	F0 concept steam sterilization sterilization safety glucose degradation products α-dicarbonyl compounds derivatization Medicine R Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/46a099a37ff84c63bdc47a7d32b6465d
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spelling	oai:doaj.org-article:46a099a37ff84c63bdc47a7d32b6465d2021-11-25T18:39:31ZQuantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation10.3390/ph141111211424-8247https://doaj.org/article/46a099a37ff84c63bdc47a7d32b6465d2021-11-01T00:00:00Zhttps://www.mdpi.com/1424-8247/14/11/1121https://doaj.org/toc/1424-8247Heat sterilization of glucose solutions can lead to the formation of various glucose degradation products (GDPs) due to oxidation, hydrolysis, and dehydration. GDPs can have toxic effects after parenteral administration due to their high reactivity. In this study, the application of the F0 concept to modify specific time/temperature models during heat sterilization and their influence on the formation of GDPs in parenteral glucose solutions was investigated using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). Glucose solutions (10%, <i>w</i>/<i>v</i>) were autoclaved at 111 °C, 116 °C, and 121 °C for different durations. The GDPs glyoxal, methylglyoxal, glucosone, 3-deoxyglucosone/3-deoxygalactosone, 3,4-dideoxyglucosone-3-ene, and 5-hydroxymethylfurfural were quantified after derivatization with o-phenylenediamine by an optimized LC-MS/MS method. For all GDPs, the limit of detection was <0.078 μg/mL, and the limit of quantification was <0.236 μg/mL. The autoclaving time of 121 °C and 15 min resulted in the lowest levels of 3-DG/3-DGal and 5-HMF, but in the highest levels of GO and 2-KDG. The proposed LC-MS/MS method is rapid and sensitive. So far, only 5-HMF concentrations are limited by the regulatory authorities. Our results suggest reconsidering the impurity limits of various GDPs, especially the more toxic ones such as GO and MGO, by the Pharmacopoeias.Sarah LeitzenMatthias VogelMichael SteffensThomas ZapfChrista Elisabeth MüllerMartin BrandlMDPI AGarticleF0 conceptsteam sterilizationsterilization safetyglucose degradation productsα-dicarbonyl compoundsderivatizationMedicineRPharmacy and materia medicaRS1-441ENPharmaceuticals, Vol 14, Iss 1121, p 1121 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	F0 concept steam sterilization sterilization safety glucose degradation products α-dicarbonyl compounds derivatization Medicine R Pharmacy and materia medica RS1-441
spellingShingle	F0 concept steam sterilization sterilization safety glucose degradation products α-dicarbonyl compounds derivatization Medicine R Pharmacy and materia medica RS1-441 Sarah Leitzen Matthias Vogel Michael Steffens Thomas Zapf Christa Elisabeth Müller Martin Brandl Quantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation
description	Heat sterilization of glucose solutions can lead to the formation of various glucose degradation products (GDPs) due to oxidation, hydrolysis, and dehydration. GDPs can have toxic effects after parenteral administration due to their high reactivity. In this study, the application of the F0 concept to modify specific time/temperature models during heat sterilization and their influence on the formation of GDPs in parenteral glucose solutions was investigated using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). Glucose solutions (10%, <i>w</i>/<i>v</i>) were autoclaved at 111 °C, 116 °C, and 121 °C for different durations. The GDPs glyoxal, methylglyoxal, glucosone, 3-deoxyglucosone/3-deoxygalactosone, 3,4-dideoxyglucosone-3-ene, and 5-hydroxymethylfurfural were quantified after derivatization with o-phenylenediamine by an optimized LC-MS/MS method. For all GDPs, the limit of detection was <0.078 μg/mL, and the limit of quantification was <0.236 μg/mL. The autoclaving time of 121 °C and 15 min resulted in the lowest levels of 3-DG/3-DGal and 5-HMF, but in the highest levels of GO and 2-KDG. The proposed LC-MS/MS method is rapid and sensitive. So far, only 5-HMF concentrations are limited by the regulatory authorities. Our results suggest reconsidering the impurity limits of various GDPs, especially the more toxic ones such as GO and MGO, by the Pharmacopoeias.
format	article
author	Sarah Leitzen Matthias Vogel Michael Steffens Thomas Zapf Christa Elisabeth Müller Martin Brandl
author_facet	Sarah Leitzen Matthias Vogel Michael Steffens Thomas Zapf Christa Elisabeth Müller Martin Brandl
author_sort	Sarah Leitzen
title	Quantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation
title_short	Quantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation
title_full	Quantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation
title_fullStr	Quantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation
title_full_unstemmed	Quantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation
title_sort	quantification of degradation products formed during heat sterilization of glucose solutions by lc-ms/ms: impact of autoclaving temperature and duration on degradation
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/46a099a37ff84c63bdc47a7d32b6465d
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Quantification of Degradation Products Formed during Heat Sterilization of Glucose Solutions by LC-MS/MS: Impact of Autoclaving Temperature and Duration on Degradation

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