Use of capillary electrophoresis for the determination of impurities in preparations of fluorine-18 labelled PET radiopharmaceuticals

Antuganov, Dmitrii; Antuganova, Yulija; Зыкова, Т. А.; Красикова, Р. Н.

doi:10.1016/j.jpba.2019.05.016

Cited by 7 publications

(4 citation statements)

References 24 publications

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“…Following acid hydrolysis with 12 m HCl (130 °C, 10 min) and HPLC purification in the ethanol‐based mobile phase, 4‐[ 18 F]FPhA was obtained in RCY of 35–38 % (non‐optimized, corrected for radioactive decay) within 90 min. The amount of copper in the final preparation was determined by earlier developed method of capillary electrophoresis . The residual amount was less than 10 ppm which is below the copper limit of 25 ppm recommended in the ICH Guideline of Elemental Impurities (Q3D).…”

Section: Resultsmentioning

confidence: 99%

Copper‐Mediated Radiofluorination of Aryl Pinacolboronate Esters: A Straightforward Protocol by Using Pyridinium Sulfonates

et al. 2018

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Radiofluorination of arylboronic acids pinacol esters (arylBPin) mediated by copper triflate pyridine complex is one of the more promising synthetic approaches for the direct introduction of nucleophilic [18F]fluoride into non‐activated arenes and heteroarenes. However, the application of this method to the production of positron emission tomography (PET) radiotracers in automated synthesizers remains a challenging task. The choice of phase‐transfer catalyst (PTC) and corresponding base used for the generation of reactive [18F]fluoride species has a profound impact on the efficiency of the 18F‐fluorination process. Herein we report the development of a simple procedure involving trapping of the aqueous [18F]fluoride on a weak anion‐exchange resin (WAX) and its release by elution with pyridinium sulfonate in dimethyl acetamide. Obtained reactive [18F]fluoride was used as‐is in a copper‐catalyzed fluorination reaction employing pyridinium salt as both PTC and base. High radiochemical conversion rates (RCCs) achieved for a series of simple arylBPin substrates and 4‐[18F]fluoro‐D,L‐phenylalanine demonstrate the efficiency of this novel 18F‐processing approach. Notably, the proposed method obviates conventional azeotropic drying steps, solvents evaporation and/or changeover and can be implemented on commercial automated synthesizers.

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Section: Resultsmentioning

confidence: 99%

Copper‐Mediated Radiofluorination of Aryl Pinacolboronate Esters: A Straightforward Protocol by Using Pyridinium Sulfonates

et al. 2018

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“…A list of CZE‐UV methods applicable to quality control analyses of pharmaceuticals published during the last 5 years is provided in Table 1 [30–52]. Such a typical procedure was introduced by Mufusama et al [33].…”

Section: Capillary Zone Electrophoresismentioning

confidence: 99%

“…Antuganov et al introduced a method for quality control analyses of potentially toxic impurities in the final preparations of 18 F-labelled radiopharmaceuticals commonly applied in preclinical and clinical positron emission tomography imaging [37]. The optimized procedure enabled the determination of copper (II), Kryptofix ® 222, Me 3 SnCl, nickel (II), tetrabutylammonium trifluoromethanesulfonate, tetraethylammonium hydrogen carbonate, and 4-dimethylaminopyridinium trifluoromethanesulfonate using 20 mM benzimidazole and 40 mM acetic acid as a BGE.…”

Section: Cze-uvmentioning

confidence: 99%

Capillary electrophoretic methods for quality control analyses of pharmaceuticals: A review

Řemínek

Foret

2020

Electrophoresis

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Capillary electrophoresis represents a promising technique in the field of pharmaceutical analysis. The presented review provides a summary of capillary electrophoretic methods suitable for routine quality control analyses of small molecule drugs published since 2015. In total, more than 80 discussed methods are sorted into three main sections according to the applied electroseparation modes (capillary zone electrophoresis, electrokinetic chromatography, and micellar, microemulsion, and liposome-electrokinetic chromatography) and further subsections according to the applied detection techniques (UV, capacitively coupled contactless conductivity detection, and mass spectrometry). Key parameters of the procedures are summarized in four concise tables. The presented applications cover analyses of active pharmaceutical ingredients and their related substances such as degradation products or enantiomeric impurities. The contribution of reported results to the current knowledge of separation science and general aspects of the practical applications of capillary electrophoretic methods are also discussed.

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“…For the determination of metal impurities, inductively coupled plasma-mass-spectrometry (ICP-MS) methods must be resorted to an outsource basis, as this kind of analytical equipment is not commonly available in clinical or even academic PET centers. As a viable alternative, Antuganov et al [ 88 ] have recently proposed capillary electrophoresis (CE) as a simple, fast and cost-efficient analytical method allowing for concurrent determination of a number of potentially toxic impurities, including copper and tin, in buffered solutions of PET radiopharmaceuticals.…”

Section: Late Stage Fluorinationsmentioning

confidence: 99%

Nucleophilic Synthesis of 6-l-[18F]FDOPA. Is Copper-Mediated Radiofluorination the Answer?

Красикова

2020

Molecules

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Positron emission tomography employing 6-l-[18F]fluoro-3,4-dihydroxyphenylalanine (6-l-[18F]FDOPA) is currently a highly relevant clinical tool for detection of gliomas, neuroendocrine tumors and evaluation of Parkinson’s disease progression. Yet, the deficiencies of electrophilic synthesis of 6-l-[18F]FDOPA hold back its wider use. To fulfill growing clinical demands for this radiotracer, novel synthetic strategies via direct nucleophilic 18F-radiloabeling starting from multi-Curie amounts of [18F]fluoride, have been recently introduced. In particular, Cu-mediated radiofluorination of arylpinacol boronates and arylstannanes show significant promise for introduction into clinical practice. In this short review these current developments will be discussed with a focus on their applicability to automation.

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Use of capillary electrophoresis for the determination of impurities in preparations of fluorine-18 labelled PET radiopharmaceuticals

Cited by 7 publications

References 24 publications

Copper‐Mediated Radiofluorination of Aryl Pinacolboronate Esters: A Straightforward Protocol by Using Pyridinium Sulfonates

Copper‐Mediated Radiofluorination of Aryl Pinacolboronate Esters: A Straightforward Protocol by Using Pyridinium Sulfonates

Capillary electrophoretic methods for quality control analyses of pharmaceuticals: A review

Nucleophilic Synthesis of 6-l-[18F]FDOPA. Is Copper-Mediated Radiofluorination the Answer?

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