Development of a rapid HPLC method for quantification of the copper tetramibi tetraflourborate in Kit for preparation of Technetium 99m Sestamibi Injection.

Radiopharmaceuticals are radioactive compounds that can be used for diagnostic and therapeutic purposes. Technetium (99mTc) Sestamibi is the most commercialized radiopharmaceutical in the world. It includes a coordination complex consisting of the radioisotope 99m Technetium bound to six copper tetramibi tetrafluorborate ligands, which is mainly used to image the myocardium via scintigraphy. As radiopharmaceuticals are regarded as drugs, they are subject to the same regulations; therefore, the objective of this study is to develop a quantification method for the active pharmaceutical ingredient before their complexation with the radioisotope by employing high-performance liquid chromatography (HPLC) methodology. A simple and efficient method (Rt = 2.5 minutes) was developed and validated for copper tetramibi tetrafluorborate in final product by using a buffer and organic solvent mixtures (ACN:Methanol: ammonium sulfate buffer) and a C18 column. Analytical protocol was fast, taking around 30 minutes until results evaluation. The validation parameters were evaluated with satisfactory results: in terms of linearity, there was r > 0.99 (160 - 240 μg/mL) and no deviation has been observed. The RSD of precision was inferior to 5%, and the average recovery of 99% was observed for accuracy. The proposed method was thus considered adequate for pharmaceutical industries routine.