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dc.contributor.authorMachioli, Lilian Fanfapt_BR
dc.contributor.authorRosa, Gabriele Cavalcantept_BR
dc.contributor.authorCarlos, Gracielapt_BR
dc.contributor.authorMendez, Andreas Sebastian Loureiropt_BR
dc.date.accessioned2023-08-31T03:34:15Zpt_BR
dc.date.issued2023pt_BR
dc.identifier.issn2527-2616pt_BR
dc.identifier.urihttp://hdl.handle.net/10183/264199pt_BR
dc.description.abstractQuantification of drugs is an essential part for ensuring quality, safety and efficacy of pharmaceutical formulations. For this, validated methods must be used in order to guarantee analytical reliability during monitoring in clinical studies and quality control. In the present study, we aim to develop a reliable, accurate, accessible and rapid UV-VIS spectrophotometry method for quantification of ceftaroline fosamil in powder for intravenous administration. Each analyzed solution was prepared individually and the only reagent used was Milli-Q water, as a solvent, making the method eco-friendly. The absorbances were measured at 242 nm, the peak absorbance found for the drug. The developed method was validated according to ICH and ANVISA guidelines, proving to be specific and demonstrating good linearity in the concentration range of 5 μg.mL-1 to 15 μg.mL-1, with determination (r2) and correlation coefficients (r) equal to 0.9999. The limits of detection and quantification found were acceptable (0.51 μg.mL-1 and 1.55 μg.mL-1, respectively). The method exhibited excellent intermediate precision and repeatability, with relative standard deviation values of 0.87% and 0.98%, respectively. Furthermore, the method’s accuracy was confirmed, showing a mean recovery of 100 ± 2.67%. Additionally, the robustness was assayed and confirmed using Plackett-Burmann design. In conclusion, the method can easily be applied for routine quality control analysis.en
dc.format.mimetypeapplication/pdfpt_BR
dc.language.isoengpt_BR
dc.relation.ispartofDrug analytical research. Porto Alegre (RS). Vol. 7, n. 1 (jan./jun. 2023), p. 46-51pt_BR
dc.rightsOpen Accessen
dc.subjectCeftaroline fosamilen
dc.subjectEspectrofotometria ultravioletapt_BR
dc.subjectUV spectrophotometryen
dc.subjectControle de qualidade : Medicamentospt_BR
dc.subjectValidationen
dc.subjectQuality controlen
dc.titleDevelopment and validation of a new analytical method based on UV-visible spectroscopy for quantification of ceftaroline fosamil in powder for injectionpt_BR
dc.typeArtigo de periódicopt_BR
dc.identifier.nrb001174912pt_BR
dc.type.originNacionalpt_BR


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