RESUMO
The goal of this study was to apply the principles of analytical quality by design (AQbD) to the analytical method for determining the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, utilizing thin-layer chromatography (TLC) with a radio-TLC scanner, which also enables the evaluation of product quality. For AQbD, the analytical target profile (ATP), critical quality attributes (CQA), risk management, and the method operable design region (MODR) were defined through response surface methodology to optimize the method using MINITAB® 19 software. This study encompassed the establishment of a control strategy and the validation of the method, including the assessment of selectivity, linearity, precision, robustness, detection limit, quantification limit, range, and the stability of the sample solution. Under the experimental conditions, the method parameters of the TLC scanner were experimentally demonstrated and optimized with an injection volume of 3 µL, a radioactive concentration of 10 mCi/mL, and a carrier volume of 40 µL. Statistical analysis confirmed the method's selectivity for the 131I iodide band Rf of 0.8, a radiochemical impurity IO3- Rf of 0.6, a linearity from 6.0 to 22.0 mCi/mL, and an intermediate precision with a global relative standard deviation (RSD) of 0.624%. The method also exhibited robustness, with a global RSD of 0.101%, a detection limit of 0.09 mCi/mL, and a quantification limit of 0.53 Ci/mL, meeting the prescribed range and displaying stability over time (at 0, 2, and 20 h) with a global RSD of 0.362%, resulting in consistent outcomes. The development of a method based on AQbD facilitated the creation of a design space and an operational space, with comprehensive knowledge of the method's characteristics and limitations. Additionally, throughout all operations, compliance with the acceptance criteria was verified. The method's validity was confirmed under the established conditions, making it suitable for use in the manufacturing process of sodium iodide 131I and application in nuclear medicine services.
Assuntos
Radioisótopos do Iodo , Compostos Radiofarmacêuticos , Iodeto de Sódio , Cromatografia em Camada Fina/métodos , Compostos Radiofarmacêuticos/química , Compostos Radiofarmacêuticos/análise , Radioisótopos do Iodo/análise , Iodeto de Sódio/química , Administração Oral , Reprodutibilidade dos TestesRESUMO
Existe un gran potencial en las plantas de la selva amazónica; en los últimos años los usos etnobotánicos fueron avalados por estudios científicos, como es el caso de diversas especies del género Handroanthus, el presente trabajo hace una revisión de las publicaciones, a la fecha, que estudian el Handroanthus obscurus (Bureau & K. Schum.) Mattos "tahuarí".
There is great potential in plants present in the Amazon region, in the last years the ethnobotanical uses were endorsed by scientific studies, as it is the case of diverse species of the genus Handroanthus, the present work makes a revision of the publications to the date that they study the Handroanthus obscurus (Bureau & K. Schum.) Mattos "tahuarí".