A mild anion-exchange HPLC method for analysis of [ 18 F]sodium fluoride solution for injection
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A mild anion-exchange HPLC method for analysis of [18F]sodium fluoride solution for injection Fei Cai1,2 · Heng Yan1 · Wenbin Fan1 · Shihong Li1 · Jianfeng Xu1,2 · Zheng Wang1 · Xiaobin Tang2 Received: 18 May 2020 © Akadémiai Kiadó, Budapest, Hungary 2020
Abstract A mild HPLC method for the quality control of [18F]sodium fluoride solution for injection was developed. The method used anion exchange column for separation, UV and online radio-detectors for fluoride content and fluorine-18 determination. A mixture of 100 mM sodium acetate and 25 mM sodium chloride was chosen as mobile phase. The method was validated for system suitability, specificity, fluoride concentration and radiochemical purity determination with good linearity, accuracy and precision. The good robustness of the system was also verified, enabling routine analysis of fluoride content and radiochemical purity of the [18F]sodium fluoride product. Keywords [18F]sodium fluoride · Anion-exchange · HPLC · Mixture mobile phase · Online radio-detection
Introduction [18F]sodium fluoride ( [18F]NaF) solution for injection is a sterile radiopharmaceutical drug, which is an excellent bone-seeking positron emission tomography (PET) tracer for detection of osteogenic abnormalities [1–3]. [18F]NaF was initially used for bone scintigraphy in early 1960’s and approved by the United States Food and Drug Administration (FDA) in 1972 [4]. The early stage clinical use of [ 18F] NaF was limited and the gamma bone scintigraphy tracer, [99mTc]Tc-methylene diphosphonate ([99mTc]Tc-MDP) has been commonly used in nuclear medicine. Recently with the global supply shortage of technetium-99 m sources and clinical advances of PET/CT technique with high resolution, [18F]NaF has drawn new interest in nuclear medicine. The [18F]NaF PET imaging affords more sensitive and accurate localization and characterization of bone lesions Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10967-020-07352-w) contains supplementary material, which is available to authorized users. * Shihong Li [email protected] 1
JYAMS PET Research and Development Limited, No. 568 Longmian Ave, Nanjing 211100, People’s Republic of China
Department of Nuclear Sciences and Engineering, Nanjing University of Aeronautics and Astronautics, 29 Yudao Street, Nanjing 210016, People’s Republic of China
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in metabolic bone diseases than gamma planar or SPECT imaging [4–6]. Furthermore, [18F]NaF PET imaging can improve the workflow of clinical nuclear medicine and patient convenience. According to European Pharmacopoeia (EP), the assay of fluoride content of [ 18F]NaF is required to ensure no more than 4.52 mg F-/V, where V is the maximum recommended dose in milliliters at the expiration time [7]. Measurement of the radiochemical purity (RCP) of [18F]NaF solution is necessary to meet the quality control requirements. Several analysis methods, including TLC [8, 9] and HPLC were reported to measure RCP of [ 18F]NaF [7, 10–14]. HPLC methods could mea
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