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001-es BibID:	BIBFORM125638
035-os BibID:	(Scopus)85201638761 (WOS)001304779300002
Első szerző:	Pajaziti, B. A.
Cím:	Optimization of a mass spectrometric analytical method for the quality assessment of insulin and its analogs / Pajaziti B. A.; Andrási M.; Nebija D.; Kemlendi N.; Pajaziti B.
Dátum:	2024
ISSN:	0031-7144
Megjegyzések:	The principal aim of this study was to optimize analytical methodology based on mass spectrometry for the evaluation of the quality of recombinant human insulin and its analogs. In this study ESI-MS was used to assess the quality of human insulin, short acting insulin analogs, insulin lispro, insulin aspart and insulin glulisine and long acting analogs including insulin glargine, insulin degludec, and insulin detemir, in respective pharmaceutical formulations. In this study, with the aimed to optimize analytical conditions, different factors influencing the analytical performance such as pH, ionic strength, sample dilution, organic solvent addition were addressed. The study results demonstrated that MS is a suitable technique for the analysis of biotechnological compounds like insulin and its analogs. Although the obtained results provide an important information regarding this methodology, further studies are needed to validate this analytical approach and check for its suitability to be used in the regulatory environment. ? 2024 Avoxa - Mediengruppe Deutscher Apotheker GmbH. All rights reserved.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény hazai lapban folyóiratcikk
Megjelenés:	Pharmazie. - 79 : 7-8 (2024), p. 146-150. -
További szerzők:	Andrási Melinda (1979-) (gyógyszerész) Nebija, D. Kemlendi N. Pajaziti, Blerta
Internet cím:	DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM104093
035-os BibID:	(WOS)000584408900003 (Scopus)85084557316
Első szerző:	Pajaziti, Blerta
Cím:	Application of the capillary zone electrophoresis (CZE) and capillary gel electrophoresis (CGE) for the separation of human insulin, insulin lispro and their degradation products / B. Pajaziti, R. Petkovska, M. Andrási, D. Nebija
Dátum:	2020
ISSN:	0031-7144
Megjegyzések:	Two capillary electrophoresis (CE) methods have been developed for the separation of charge and mass variants of human insulin and its recombinant analogue lispro. Since the capillary zone (CZE) and Capillary gel electrophoresis (CGE) are based on different principles of separation, they can be used to detect different impurities of insulin and its analogues. Application of CZE enabled a separation of compounds with different m/z ratio, therefore CZE is a suitable method for the separation of deamidation products of insulin. After the optimization, this method is validated according ICH requirements. CGE method was used for the separation of higher molecular weight transformation products. Experimental data have shown that CZE and CGE are simple, fast and robust methods which could be used as a routine analysis for quality control of insulin formulations.
Tárgyszavak:	Természettudományok Kémiai tudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Pharmazie. - 75 (2020), p. 167-171. -
További szerzők:	Petkovska, R. Andrási Melinda (1979-) (gyógyszerész) Nebija, D.
Pályázati támogatás:	NKFIH-K-127931 Egyéb
Internet cím:	DOI Intézményi repozitóriumban (DEA) tárolt változat
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