Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulation
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 o...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
São Paulo State University (UNESP)
2021-02-01
|
| Series: | Revista de Ciências Farmacêuticas Básica e Aplicada |
| Subjects: | |
| Online Access: | http://rcfba.fcfar.unesp.br/index.php/ojs/article/view/712 |
| _version_ | 1818339102052843520 |
|---|---|
| author | Danilo R. O. Momade Raquel de O. Vilhena Carolina Castro Fabiana Regis Karime Zeraik Abdalla Domingues Laís Schlichta Alexandre de Fátima Cobre Roberto Pontarolo |
| author_facet | Danilo R. O. Momade Raquel de O. Vilhena Carolina Castro Fabiana Regis Karime Zeraik Abdalla Domingues Laís Schlichta Alexandre de Fátima Cobre Roberto Pontarolo |
| author_sort | Danilo R. O. Momade |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T15:21:40Z |
| format | Article |
| id | doaj.art-77a0bfb8e4bf4896b97f08b4688fd4c6 |
| institution | Directory Open Access Journal |
| issn | 1808-4532 2179-443X |
| language | English |
| last_indexed | 2024-12-13T15:21:40Z |
| publishDate | 2021-02-01 |
| publisher | São Paulo State University (UNESP) |
| record_format | Article |
| series | Revista de Ciências Farmacêuticas Básica e Aplicada |
| spelling | doaj.art-77a0bfb8e4bf4896b97f08b4688fd4c62022-12-21T23:40:33ZengSão Paulo State University (UNESP)Revista de Ciências Farmacêuticas Básica e Aplicada1808-45322179-443X2021-02-014218712Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulationDanilo R. O. Momade0Raquel de O. Vilhena1Carolina Castro2Fabiana Regis3Karime Zeraik Abdalla Domingues4Laís Schlichta5Alexandre de Fátima Cobre6Roberto Pontarolo7Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, BrasilDepartamento de Farmácia, Universidade Federal do Paraná (UFPR), Curitiba, PR, BrasilPrograma de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, BrasilPrograma de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, BrasilPrograma de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, BrasilPrograma de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, BrasilPrograma de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Paraná (UFPR), Curitiba, PR, BrasilDepartamento de Farmácia, Universidade Federal do Paraná (UFPR), Curitiba, PR, BrasilObjective. 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.http://rcfba.fcfar.unesp.br/index.php/ojs/article/view/712analytical validationoclacitinibuv-vis spectrophotometric |
| spellingShingle | Danilo R. O. Momade Raquel de O. Vilhena Carolina Castro Fabiana Regis Karime Zeraik Abdalla Domingues Laís Schlichta Alexandre de Fátima Cobre Roberto Pontarolo Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulation Revista de Ciências Farmacêuticas Básica e Aplicada analytical validation oclacitinib uv-vis spectrophotometric |
| title | Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulation |
| title_full | Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulation |
| title_fullStr | Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulation |
| title_full_unstemmed | Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulation |
| title_short | Development and validation of an UV-Vis spectrophotometric method for the quantification of oclacitinib in capsule formulation |
| title_sort | development and validation of an uv vis spectrophotometric method for the quantification of oclacitinib in capsule formulation |
| topic | analytical validation oclacitinib uv-vis spectrophotometric |
| url | http://rcfba.fcfar.unesp.br/index.php/ojs/article/view/712 |
| work_keys_str_mv | AT daniloromomade developmentandvalidationofanuvvisspectrophotometricmethodforthequantificationofoclacitinibincapsuleformulation AT raqueldeovilhena developmentandvalidationofanuvvisspectrophotometricmethodforthequantificationofoclacitinibincapsuleformulation AT carolinacastro developmentandvalidationofanuvvisspectrophotometricmethodforthequantificationofoclacitinibincapsuleformulation AT fabianaregis developmentandvalidationofanuvvisspectrophotometricmethodforthequantificationofoclacitinibincapsuleformulation AT karimezeraikabdalladomingues developmentandvalidationofanuvvisspectrophotometricmethodforthequantificationofoclacitinibincapsuleformulation AT laisschlichta developmentandvalidationofanuvvisspectrophotometricmethodforthequantificationofoclacitinibincapsuleformulation AT alexandredefatimacobre developmentandvalidationofanuvvisspectrophotometricmethodforthequantificationofoclacitinibincapsuleformulation AT robertopontarolo developmentandvalidationofanuvvisspectrophotometricmethodforthequantificationofoclacitinibincapsuleformulation |