Počet záznamů: 1
Application of capillary electrophoresis-nano-electrospray ionization-mass spectrometry for the determination of N-nitrosodimethylamine in pharmaceuticals
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SYSNO ASEP 0538745 Druh ASEP J - Článek v odborném periodiku Zařazení RIV J - Článek v odborném periodiku Poddruh J Článek ve WOS Název Application of capillary electrophoresis-nano-electrospray ionization-mass spectrometry for the determination of N-nitrosodimethylamine in pharmaceuticals Tvůrce(i) Řemínek, Roman (UIACH-O) ORCID
Foret, František (UIACH-O) RID, ORCID
Chung, D. S. (KR)Celkový počet autorů 3 Zdroj.dok. Electrophoresis. - : Wiley - ISSN 0173-0835
Roč. 42, č. 4 (2021), s. 334-341Poč.str. 8 s. Forma vydání Tištěná - P Jazyk dok. eng - angličtina Země vyd. DE - Německo Klíč. slova capillary electrophoresis ; mass spectrometry ; nano-electrospray ionization ; N-nitrosodimethylamine Vědní obor RIV CB - Analytická chemie, separace Obor OECD Analytical chemistry Vědní obor RIV – spolupráce Ústav analytické chemie - Analytická chemie, separace CEP 8F17003 GA MŠMT - Ministerstvo školství, mládeže a tělovýchovy Způsob publikování Omezený přístup Institucionální podpora UIACH-O - RVO:68081715 UT WOS 000607573500001 EID SCOPUS 85099377101 DOI 10.1002/elps.202000303 Anotace After a presence of highly hepatotoxic and potentially carcinogenic N-nitrosodimethylamine was detected in certain lots of sartan, ranitidine, metformin, and other pharmaceuticals, local regulatory authorities issued recalls of suspected products, and concerns of the pharmacotherapy safety were widely discussed. Since then, testing of a representative sample of each produced lot of these pharmaceuticals is required as a part of quality control processes. Hence, an interface-free CE-nanoESI system coupled with MS detection was employed for the development of a simple and economical method for quantitative detection of this contaminant in the valsartan drug substances and finished formulations used as model matrices. In this arrangement, a fused-silica capillary was used as both a separation column and a nanoESI emitter providing high ionization efficiency and sensitivity. The optimized procedure was found to have sufficient selectivity, linearity, accuracy, and precision. The established LOD and LOQ values were 0.3 and 1.0 ng/mL, respectively. The practical applicability of the method was tested by analyses of commercially available Valsacor(R) tablets. The results obtained prove that the developed procedure represents a promising alternative to currently available GC- and LC-based methods. Furthermore, after an adjustment of the separation conditions, the CE-nanoESI/MS system can be conceptually used for the determination of NDMA in other suspected pharmaceuticals. Pracoviště Ústav analytické chemie Kontakt Iveta Drobníková, drobnikova@iach.cz, Tel.: 532 290 234 Rok sběru 2022 Elektronická adresa http://hdl.handle.net/11104/0316481
Počet záznamů: 1