PreprintArticleVersion 1Preserved in Portico This version is not peer-reviewed
Analytical Quality by Design (AQbD) of the TLCScanner Method for the Determination of Radiochemical Purity of the Radiopharmaceutical Sodium Iodide 131I Oral Solution
Vasquez-Huaman, M.; Castro-Luna, A.; Ramos-Cevallos, N.J.; Ramos-Perfecto, D.; Alcarraz-Curi, M.; Segura-Vasquez, J.; Cáceres-Antaurco, D. Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide 131I Oral Solution. Molecules2024, 29, 1883.
Vasquez-Huaman, M.; Castro-Luna, A.; Ramos-Cevallos, N.J.; Ramos-Perfecto, D.; Alcarraz-Curi, M.; Segura-Vasquez, J.; Cáceres-Antaurco, D. Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide 131I Oral Solution. Molecules 2024, 29, 1883.
Vasquez-Huaman, M.; Castro-Luna, A.; Ramos-Cevallos, N.J.; Ramos-Perfecto, D.; Alcarraz-Curi, M.; Segura-Vasquez, J.; Cáceres-Antaurco, D. Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide 131I Oral Solution. Molecules2024, 29, 1883.
Vasquez-Huaman, M.; Castro-Luna, A.; Ramos-Cevallos, N.J.; Ramos-Perfecto, D.; Alcarraz-Curi, M.; Segura-Vasquez, J.; Cáceres-Antaurco, D. Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide 131I Oral Solution. Molecules 2024, 29, 1883.
Abstract
The objective of the study was to apply the principles of analytical quality by design (AQbD) to the analytical method for the determination of the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, by means of thin layer chromatography (TLC) with a Radio-TLC scanner, the same one that allows to evaluate the quality of the product. For the AQbD, the analytical objective profile (ATP), critical quality attributes (CQA), risk management, the method operable design region (MODR) were defined through the response surface methodology for method optimization using the MINITAB ® software, Control Strategy and the validation of the method where the parameters of selectivity, linearity, precision, robustness, detection limit, quantification limit, range and stability of the sample solution were evaluated. Under the experimental conditions, the conditions of the method were demonstrated by TLC-Scanner and optimization was carried out for an injection volume of 3 µL, radioactive concentration of 10 mCi/mL and carrier volume of 40 µL. It was statistically demonstrated that the method is selective for the 131I iodide band Rf of 0,8 and for the radiochemical impurity IO₃⁻ Rf of 0.6, linearity from 6,0 to 22.0 mCi/mL, intermediate precision with Global RSD of 0,624%, robustness with global RSD 0,101%, detection limit of 0,09 mCi/mL, quantification limit of 0.53 Ci/mL, conforming range, and stability of the sample solution evaluated over time 0, 2 and 20 hours with a global RSD of 0,362%, obtaining consistent results. The development of the method based on AQbD allowed the generation of a design space and an operational space with knowledge of all the characteristics and limitations of the method, likewise in all the operations the conformity of the tests to the acceptance criteria was verified. The validity of our method is concluded under the established conditions, suitable for use in the manufacturing process of sodium iodide 131I and application in nuclear medicine services.
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
,
,
,
,
,
*
,
