Kinetics and Characterization of Degradation Products of Dihydralazine and Hydrochlorothiazide in Binary Mixture by HPLC-UV, LC-DAD and LC–MS Methods

Dihydralazine and hydrochlorothiazide were stored at high temperature and humidity, under UV/Vis light and different pH, as individual drugs and the mixture. Then, a sensitive and selective HPLC-UV method was developed for simultaneous determination of dihydralazine and hydrochlorothiazide in presen...

Descripción completa

Detalles Bibliográficos
Autores principales: Gumieniczek, Anna, Galeza, Justyna, Mroczek, Tomasz, Wojtanowski, Krzysztof, Lipska, Katarzyna, Pietras, Rafał
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132553/
https://www.ncbi.nlm.nih.gov/pubmed/30220731
http://dx.doi.org/10.1007/s10337-018-3555-8
_version_ 1783354341914050560
author Gumieniczek, Anna
Galeza, Justyna
Mroczek, Tomasz
Wojtanowski, Krzysztof
Lipska, Katarzyna
Pietras, Rafał
author_facet Gumieniczek, Anna
Galeza, Justyna
Mroczek, Tomasz
Wojtanowski, Krzysztof
Lipska, Katarzyna
Pietras, Rafał
author_sort Gumieniczek, Anna
collection PubMed
description Dihydralazine and hydrochlorothiazide were stored at high temperature and humidity, under UV/Vis light and different pH, as individual drugs and the mixture. Then, a sensitive and selective HPLC-UV method was developed for simultaneous determination of dihydralazine and hydrochlorothiazide in presence of their degradation products. Finally, the degradation products were characterized through LC-DAD and LC–MS methods. Dihydralazine was sensitive to high temperature and humidity, UV/Vis light and pH ≥ 7. At the same time, it was resistant to acidic conditions. Hydrochlorothiazide was sensitive to high temperature and humidity, UV/Vis light and changes in pH. Its highest level of degradation was observed in 1 M HCl. Degradation of the drugs was higher when they were stressed in the mixture. In the case of dihydralazine, the percentage degradation was 5–15 times higher. What is more, dihydralazine became sensitive to acidic conditions. Hydrochlorothiazide was shown to be more sensitive to UV/Vis light and pH > 4. Degradation of dihydralazine and hydrochlorothiazide followed first-order kinetics. The quickest degradation of dihydralazine was found to be in 1 M NaOH while of hydrochlorothiazide was in 1 M HCl (individual hydrochlorothiazide) or at pH 7–10 (hydrochlorothiazide in the mixture). A number of new degradation products were detected and some of them were identified by our LC-DAD and LC–MS methods. In the stressed individual samples, (phenylmethyl)hydrazine and 1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide were observed for the first time. Interactions between dihydralazine and hydrochlorothiazide in the mixture were confirmed by additional degradation products, e.g., 2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1,4-trioxide.
format Online
Article
Text
id pubmed-6132553
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher Springer Berlin Heidelberg
record_format MEDLINE/PubMed
spelling pubmed-61325532018-09-14 Kinetics and Characterization of Degradation Products of Dihydralazine and Hydrochlorothiazide in Binary Mixture by HPLC-UV, LC-DAD and LC–MS Methods Gumieniczek, Anna Galeza, Justyna Mroczek, Tomasz Wojtanowski, Krzysztof Lipska, Katarzyna Pietras, Rafał Chromatographia Original Dihydralazine and hydrochlorothiazide were stored at high temperature and humidity, under UV/Vis light and different pH, as individual drugs and the mixture. Then, a sensitive and selective HPLC-UV method was developed for simultaneous determination of dihydralazine and hydrochlorothiazide in presence of their degradation products. Finally, the degradation products were characterized through LC-DAD and LC–MS methods. Dihydralazine was sensitive to high temperature and humidity, UV/Vis light and pH ≥ 7. At the same time, it was resistant to acidic conditions. Hydrochlorothiazide was sensitive to high temperature and humidity, UV/Vis light and changes in pH. Its highest level of degradation was observed in 1 M HCl. Degradation of the drugs was higher when they were stressed in the mixture. In the case of dihydralazine, the percentage degradation was 5–15 times higher. What is more, dihydralazine became sensitive to acidic conditions. Hydrochlorothiazide was shown to be more sensitive to UV/Vis light and pH > 4. Degradation of dihydralazine and hydrochlorothiazide followed first-order kinetics. The quickest degradation of dihydralazine was found to be in 1 M NaOH while of hydrochlorothiazide was in 1 M HCl (individual hydrochlorothiazide) or at pH 7–10 (hydrochlorothiazide in the mixture). A number of new degradation products were detected and some of them were identified by our LC-DAD and LC–MS methods. In the stressed individual samples, (phenylmethyl)hydrazine and 1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide were observed for the first time. Interactions between dihydralazine and hydrochlorothiazide in the mixture were confirmed by additional degradation products, e.g., 2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1,4-trioxide. Springer Berlin Heidelberg 2018-06-25 2018 /pmc/articles/PMC6132553/ /pubmed/30220731 http://dx.doi.org/10.1007/s10337-018-3555-8 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original
Gumieniczek, Anna
Galeza, Justyna
Mroczek, Tomasz
Wojtanowski, Krzysztof
Lipska, Katarzyna
Pietras, Rafał
Kinetics and Characterization of Degradation Products of Dihydralazine and Hydrochlorothiazide in Binary Mixture by HPLC-UV, LC-DAD and LC–MS Methods
title Kinetics and Characterization of Degradation Products of Dihydralazine and Hydrochlorothiazide in Binary Mixture by HPLC-UV, LC-DAD and LC–MS Methods
title_full Kinetics and Characterization of Degradation Products of Dihydralazine and Hydrochlorothiazide in Binary Mixture by HPLC-UV, LC-DAD and LC–MS Methods
title_fullStr Kinetics and Characterization of Degradation Products of Dihydralazine and Hydrochlorothiazide in Binary Mixture by HPLC-UV, LC-DAD and LC–MS Methods
title_full_unstemmed Kinetics and Characterization of Degradation Products of Dihydralazine and Hydrochlorothiazide in Binary Mixture by HPLC-UV, LC-DAD and LC–MS Methods
title_short Kinetics and Characterization of Degradation Products of Dihydralazine and Hydrochlorothiazide in Binary Mixture by HPLC-UV, LC-DAD and LC–MS Methods
title_sort kinetics and characterization of degradation products of dihydralazine and hydrochlorothiazide in binary mixture by hplc-uv, lc-dad and lc–ms methods
topic Original
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132553/
https://www.ncbi.nlm.nih.gov/pubmed/30220731
http://dx.doi.org/10.1007/s10337-018-3555-8
work_keys_str_mv AT gumieniczekanna kineticsandcharacterizationofdegradationproductsofdihydralazineandhydrochlorothiazideinbinarymixturebyhplcuvlcdadandlcmsmethods
AT galezajustyna kineticsandcharacterizationofdegradationproductsofdihydralazineandhydrochlorothiazideinbinarymixturebyhplcuvlcdadandlcmsmethods
AT mroczektomasz kineticsandcharacterizationofdegradationproductsofdihydralazineandhydrochlorothiazideinbinarymixturebyhplcuvlcdadandlcmsmethods
AT wojtanowskikrzysztof kineticsandcharacterizationofdegradationproductsofdihydralazineandhydrochlorothiazideinbinarymixturebyhplcuvlcdadandlcmsmethods
AT lipskakatarzyna kineticsandcharacterizationofdegradationproductsofdihydralazineandhydrochlorothiazideinbinarymixturebyhplcuvlcdadandlcmsmethods
AT pietrasrafał kineticsandcharacterizationofdegradationproductsofdihydralazineandhydrochlorothiazideinbinarymixturebyhplcuvlcdadandlcmsmethods