Single radio UHPLC analysis for the quality control of technetium-99m radiolabelled radiopharmaceuticals

Highlights: • Technetium-99m is frequently used to prepare radiopharmaceuticals (RP). • The radiochemical purity (RCP) is evaluated by thin layer chromatography (TLC). • Ultra-high performance liquid chromatography (UHPLC) increases the sensitivity. • A single UHPLC method allows the RCP determination of 4 different ^99mTc-RP. • The UHPLC method is robust, reproducible, automated and safer than the TLC method. The radiochemical purity (RCP) determination of radiopharmaceuticals is routinely done with radio-thin layer chromatography (r-TLC). These methods are usually transposed and adjusted from the summary product characteristics without any analytical validation. The r-TLC method is simple but manually-performed steps could lead to RCP misinterpretation. To increase the sensitivity, radio ultra-high performance liquid chromatography (r-UHPLC) can be used. In this study, an r-UHPLC method had been validated and compared to the r-TLC method. Hydrolyzed-reduced technetium had also been studied.