Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulation

Danilo R. O. Momade; Raquel de O.  Vilhena; Carolina  Castro; Fabiana  Regis; Karime Zeraik Abdalla  Domingues; Laís  Schlichta; Alexandre de Fátima  Cobre; Roberto Pontarolo

Danilo R. O. Momade Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, Brasil https://orcid.org/0000-0003-3899-2300
Raquel de O. Vilhena Departamento de Farmácia, Universidade Federal do Paraná (UFPR), Curitiba, PR, Brasil https://orcid.org/0000-0002-8942-0591
Carolina Castro Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, Brasil https://orcid.org/0000-0003-1318-4913
Fabiana Regis Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, Brasil https://orcid.org/0000-0003-2703-4932
Karime Zeraik Abdalla Domingues Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, Brasil https://orcid.org/0000-0001-8510-1473
Laís Schlichta Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, Brasil https://orcid.org/0000-0002-4769-4164
Alexandre de Fátima Cobre Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, Brasil https://orcid.org/0000-0001-6642-3928
Roberto Pontarolo Departamento de Farmácia, Universidade Federal do Paraná (UFPR), Curitiba, PR, Brasil https://orcid.org/0000-0002-7049-4363

Keywords: Analytical validation, Oclacitinib, UV-Vis spectrophotometric

Abstract

Objective. The aim of this study was the development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in commercial capsule formulation since pharmacopeias have not yet provided an official monograph for this drug. Methods. The parameters linearity, limit of detection, limit of quantitation, specificity, precision, accuracy, and robustness were determined according to Brazilian and international guidelines. Results. Linearity was determined for the analytical range of 5-15 μg/mL, and a limit of detection of 1.18 μg/mL and limit of quantification of 3.58 μg/mL were obtained. The method was selective and the precision was demonstrated through repeatability and intermediate precision, with relative standard deviations of 1.96% and 1.78%, respectively. In its turn, accuracy presented recovery percentages of 98.32-100.91%. All robustness and sample stability (48 h at 25 °C) results revealed no statistical variation among the groups. Conclusions. The presented method is suitable for the quantification of oclacitinib in commercial capsule formulation.