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Ultra‐fast liquid chromatography method coupled with ultraviolet detection to quantify dimethylsulfoxide, dimethylformamide and dimethylacetamide in short half‐lives radiopharmaceuticals
Author(s) -
Fouque Julien,
Rusu Timofei,
Huguet Samuel,
Branquinho Emilie Da Costa,
BlondeelGomes Sandy,
Rezaï Keyvan,
Madar Olivier
Publication year - 2021
Publication title -
journal of labelled compounds and radiopharmaceuticals
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.432
H-Index - 47
eISSN - 1099-1344
pISSN - 0362-4803
DOI - 10.1002/jlcr.3938
Subject(s) - chemistry , dimethylacetamide , dimethylformamide , chromatography , derivatization , gas chromatography , high performance liquid chromatography , solvent , organic chemistry
Radiolabelling with short half‐lives radionuclides (e.g., fluorine‐18 and carbon‐11) must be as efficient and as fast as possible. Nucleophilic radiofluorinations and radiomethylations are conducted in polar aprotic solvents, such as dimethylsulfoxyde (DMSO), N,N‐dimethylformamide (DMF) and N,N‐dimethylacetamide (DMA), at high temperature. Those solvents are classified as toxic according to the ICH guidelines and must be evaluated in drug such as radiopharmaceuticals. Headspace gas chromatography is the standard method for the quantification of residual solvents but is not optimized for a rapid quantification of low vapor pressure solvents such as DMSO, DMF and DMA in radiopharmaceuticals. Direct injection gas chromatography is an interesting option without incubation step but the analysis run‐time remains beyond 10 min long. In consequence, we developed a very simple ultra‐high performance liquid chromatography method coupled with UV detection. Following the EMA requirements, we successfully validated a 3‐min run‐time analysis for quantification of three solvents in short half‐lives radiopharmaceuticals. We currently use this method for the quality control of radiopharmaceuticals produced in our PET center.