Isoquinoline-based intrinsic fluorescence assessment of erythropoiesis-stimulating agent, Roxadustat (FG-4592), in tablets: applications to content uniformity and human plasma evaluation.

Autor: Batakoushy HA; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Menoufia University, Shibin El Kom, Egypt., Hafez HM; Department of Pharmaceutical Chemistry, College of Pharmacy, Al-Esraa University, Baghdad, Iraq., Soliman MM; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt., Mohamed TF; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt., Ahmed AB; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Nahda University, Beni Suef, Egypt., El Hamd MA; Department of Pharmaceutical Chemistry, College of Pharmacy, Shaqra University, Shaqra, Saudi Arabia.; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, South Valley University, Qena, Egypt.
Jazyk: angličtina
Zdroj: Luminescence : the journal of biological and chemical luminescence [Luminescence] 2024 Apr; Vol. 39 (4), pp. e4741.
DOI: 10.1002/bio.4741
Abstrakt: In the present study, a first validated and green spectrofluorimetric approach for its assessment and evaluation in different matrices was investigated. After using an excitation wavelength of 345 nm, Roxadustat (ROX) demonstrates a highly native fluorescence at an emission of 410 nm. The influences of experimental factors such as pH, diluting solvents, and different organized media were tested, and the most appropriate solvent choice was ethanol. It was confirmed that there was a linear relationship between the concentration of ROX and the relative fluorescence intensity in the range 60.0-1000.0 ng ml -1, with the limit of detection and limit of quantitation, respectively, being 17.0 and 53.0 ng ml -1 . The mean recoveries % [±standard deviation (SD), n = 5] for pharmaceutical preparations were 100.11% ± 2.24%, whereas for plasma samples, they were 100.08 ± 1.08% (±SD, n = 5). The results obtained after the application of four greenness criteria, Analytical Eco-Scale metric, NEMI, GAPI, and AGREE metric, confirmed its eco-friendliness. In addition, the whiteness meter (RGB12) confirmed its level of sustainability. The International Council for Harmonisation (ICH) criteria were used to verify the developed method through the study in both spiked plasma samples and content uniformity evaluation. An appropriate standard for various applications in industry and quality control laboratories was developed.
(© 2024 John Wiley & Sons Ltd.)
Databáze: MEDLINE
Externí odkaz: