Alternative chromatographic system for the quality control of lipophilic technetium-99m radiopharmaceuticals such as [99mTc(MIBI)6]+

Abstract

Knowledge of the radiochemical purity of radiopharmaceuticals is mandatory and can be evaluated by several methods and techniques. Planar chromatography is the technique normally employed in nuclear medicine since it is simple, rapid and usually of low cost. There is no standard system for the chromatographic technique, but price, separation efficiency and short time for execution must be considered. We have studied an alternative system using common chromatographic stationary phase and alcohol or alcohol:chloroform mixtures as the mobile phase, using the lipophilic radiopharmaceutical [99mTc(MIBI)6]+ as a model. Whatman 1 modified phase paper and absolute ethanol, Whatman 1 paper and methanol:chloroform (25:75), Whatman 3MM paper and ethanol:chloroform (25:75), and the more expensive ITLC-SG and 1-propanol:chloroform (10:90) were suitable systems for the direct determination of radiochemical purity of [99mTc(MIBI)6]+ since impurities such as99mTc-reduced-hydrolyzed (RH),99mTcO4 - and [99mTc(cysteine)2]-complex were completely separated from the radiopharmaceutical, which moved toward the front of chromatographic systems while impurities were retained at the origin. The time required for analysis was 4 to 15 min, which is appropriate for nuclear medicine routines.

Validation of a cost-effective alternative for a radiochromatography method to be used in a developing country

“…Several studies describe the development of alternative chromatography procedures to replace 'gold-standard' methods for reasons including simplified technical handling and more rapid processing times. Faria et al in 2015 studied an alternative chromatographic system for the quality control of MIBI where they evaluated different solvents to optimize separation efficiency, reproducibility and analysis time (Faria et al 2015). This was, however, not a full validation study as defined in documents of normative character: ISO (International Organization for Standardization), ICH, FDA (Food and Drug Administration) (Krause 2002;USP 37 < 1225> 2008, with performance characteristics evaluated against acceptance criteria from references.…”