Validation of an analytical method by TLC-scanner for the determination of radiochemical purity of sodium pertechnetate 99mTc injectable solution

Abstract

The validation of an analytical method was carried out for the determination of the radiochemical purity of the radiopharmaceutical Pertecnetate sodium  ^99mTc solution for injection, by means of thin layer chromatography (TLC) with a Radio-TLC scanner system, which allows to evaluate the quality of the product. The parameters of selectivity, linearity, precision, robustness, limit of detection, limit of quantification, range and stability were evaluated in the sample solution. Under the experimental conditions, the TLC-scanner method was statistically demonstrated to be selective for the pertechnetate band TcO ^- Rf of 0.9 and for the radiochemical impurity TcO2 Rf of 0.1, the linearity from 0.25 to 3.0 mCi / mL, intermediate precision with overall RSD of 0.227 %, robustness with overall RSD 0.012 %, detection limit of 0.03 % mCi / mL, limit of quantification of 0.24 mCi/mL, conformal range and stability of the sample solution evaluated at times 0, 2 and 3 hours with a global RSD of 0.196 % obtaining compliant results. In all the operations, the conformity of the tests to the acceptance criteria was verified in each of the validation stages. Under the established of our method is concluded to be suitable for use in the process of g Tc sodium pertechnetate.