Validation of a HPLC-UV analytical and bioanalytical method for dexamethasone determination in nanoemulsions, porcine nasal mucosa, and mouse plasma and brain tissue

Luísa Degrandi Sehn; Gabriela Fusinatto de Oliveira; Melaine Maiara da Silva Lopes; Helder Ferreira Teixeira; Ursula da Silveira Matte; Roselena Silvestri Schuh; Flavia Nathiely Silveira Fachel

doi:10.22456/2527-2616.148019

Authors

Luísa Degrandi Sehn Programa de Pós‐Graduação em Ciências Farmacêuticas, Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul (UFRGS) https://orcid.org/0009-0001-6044-7512
Gabriela Fusinatto de Oliveira Programa de Pós‐Graduação em Ciências Farmacêuticas, Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul (UFRGS) https://orcid.org/0009-0002-1628-8574
Melaine Maiara da Silva Lopes Programa de Pós‐Graduação em Ciências Farmacêuticas, Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul (UFRGS) https://orcid.org/0000-0002-8474-137X
Helder Ferreira Teixeira Programa de Pós‐Graduação em Ciências Farmacêuticas, Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul (UFRGS) https://orcid.org/0000-0002-5808-3043
Ursula da Silveira Matte Programa de Pós‐Graduação em Ciências Farmacêuticas, Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul (UFRGS); Células, Tecidos e Genes, Centro de Pesquisa Experimental - Hospital de Clínicas de Porto Alegre https://orcid.org/0000-0003-4977-6662
Roselena Silvestri Schuh Programa de Pós‐Graduação em Ciências Farmacêuticas, Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul (UFRGS); Células, Tecidos e Genes, Centro de Pesquisa Experimental - Hospital de Clínicas de Porto Alegre https://orcid.org/0000-0003-4189-0436
Flavia Nathiely Silveira Fachel Programa de Pós‐Graduação em Ciências Farmacêuticas, Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul (UFRGS) https://orcid.org/0000-0002-0777-9497

DOI:

https://doi.org/10.22456/2527-2616.148019

Keywords:

Dexamethasone, HPLC, nanotechnology, biological matrices; nasal, human plasma, brain

Abstract

Dexamethasone (DEX) is a synthetic glucocorticoid widely used in the treatment of inflammatory and autoimmune diseases. However, its clinical efficacy is limited by low water solubility, poor bioavailability, and a high incidence of side effects. To overcome these limitations, nanotechnology-based drug delivery systems, such as nanoemulsions, have emerged as promising alternatives, particularly when combined with nasal administration targeting the treatment of neuroinflammation in the central nervous system. This study describes the validation of an analytical and bioanalytical method using high-performance liquid chromatography with ultraviolet detection (HPLC-UV) for the quantification of DEX active pharmaceutical ingredient (API) in nanoemulsions, porcine nasal mucosa, and mouse plasma and brain tissue. The method was validated according to current regulatory guidelines and was based on a procedure previously described in the 7^th edition of the Brazilian Pharmacopoeia (2024). The method demonstrated specificity, with no interference from endogenous components of the matrices. Linearity was confirmed in the range of 0.5 to 10.0 µg mL⁻¹ for standard solutions, nanoemulsion, porcine nasal mucosa, and mouse plasma, and from 1.0 to 10.0 µg mL⁻¹ for mouse brain samples, with correlation coefficients (r) greater than 0.99. The method has also been shown to be precise, accurate and with low matrix effect within regulatory acceptance criteria. These results confirm the method’s reliability for determination of DEX in both nanotechnological and biological matrices. The validated method is intended to support future performance studies of nanotechnology-based formulations for nasal administration of DEX.

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