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Appl Radiat Isot ; 142: 8-11, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30245440

ABSTRACT

A radio-analytical RP-HPLC method was developed and validated to support production of the P2X7-receptor-targeted [11C]GSK1482160 radiopharmaceutical. Method validation included characterization of retention times, peak shapes, linearity, accuracy, precision, selectivity, limits of detection and quantitation (UV signal), radiochemical stability, as well as analytical method range and robustness. The validated radio-HPLC method is suitable for the definition of [11C]GSK1482160 radiochemical identity, radiochemical purity, as well as molar activity, and is being employed in support of human studies with [11C]GSK1482160.


Subject(s)
Chromatography, High Pressure Liquid/methods , Pyrrolidonecarboxylic Acid/analysis , Pyrrolidonecarboxylic Acid/pharmacokinetics , Radiopharmaceuticals/analysis , Radiopharmaceuticals/pharmacokinetics , Receptors, Purinergic P2X7/metabolism , Chromatography, Reverse-Phase/methods , Drug Stability , Humans , Positron-Emission Tomography , Pyrrolidonecarboxylic Acid/standards , Quality Control , Radiopharmaceuticals/standards
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