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

摘要

Abstract 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 99?m technetium bound to six copper tetramibi tetrafluorborate ligands, and 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 was 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 (retention time?=?2.5?min) was developed and validated for copper tetramibi tetrafluorborate in the final product using a buffer and organic solvent mixtures (ACN–methanol–ammonium sulfate buffer) and a C 18 column. The analytical protocol was fast, taking around 30?min until evaluation of results. The validation parameters were evaluated with satisfactory results: in terms of linearity r ??0.99 (160–240?μg/mL) and no deviation was observed. The RSD of precision was 5%, and an average recovery of 99% was observed for accuracy. The proposed method was thus considered adequate for routine analysis in the pharmaceutical industries.