Chromatographic method development using multivariate approaches for organic solvents optimized analysis in [ 18 F]fluorocholine.

Autor: Costa CLS; Radiopharmaceutical Production and Development Unit, Nuclear Technology Development Center, Av. Presidente Antônio Carlos, 6627, Pampulha, Belo Horizonte, MG, Brazil. Electronic address: clsc@cdtn.br., Santos LM; Radiopharmaceutical Production and Development Unit, Nuclear Technology Development Center, Av. Presidente Antônio Carlos, 6627, Pampulha, Belo Horizonte, MG, Brazil., Castro ACF; Radiopharmaceutical Production and Development Unit, Nuclear Technology Development Center, Av. Presidente Antônio Carlos, 6627, Pampulha, Belo Horizonte, MG, Brazil., Nascimento LTC; Radiopharmaceutical Production and Development Unit, Nuclear Technology Development Center, Av. Presidente Antônio Carlos, 6627, Pampulha, Belo Horizonte, MG, Brazil., Silva JB; Radiopharmaceutical Production and Development Unit, Nuclear Technology Development Center, Av. Presidente Antônio Carlos, 6627, Pampulha, Belo Horizonte, MG, Brazil., Silveira MB; Radiopharmaceutical Production and Development Unit, Nuclear Technology Development Center, Av. Presidente Antônio Carlos, 6627, Pampulha, Belo Horizonte, MG, Brazil.
Jazyk: angličtina
Zdroj: Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine [Appl Radiat Isot] 2023 May; Vol. 195, pp. 110736. Date of Electronic Publication: 2023 Feb 20.
DOI: 10.1016/j.apradiso.2023.110736
Abstrakt: A fast and simple method using Gas Chromatography combined with Flame Ionization Detection (GC-FID) was developed for the determination of ethanol, acetonitrile, dibromomethane, dimethylaminoethanol, and dimethyl sulfoxide in [ 18 F]fluorocholine. The combination of fractional factorial design, Doehlert design, and Desirability function was used to evaluate the operational parameters and to establish the best working condition. The validation results revealed that the proposed method has good recovery (85.1-104.1%) and repeatability (RSD ≤8.1%). Correlation coefficients (R ≥ 0.983) indicated good linearity over a wide range. The limit of detection (≤2.5 ppm) and the limit of quantification (≤7.5 ppm) were satisfactory. The proposed method is based on minimum manual operation, sample preparation free, direct injection technique, and short chromatographic separation time. This method is useful for routine analysis of organic solvents in [ 18 F]fluorocholine, feasible for the modernization of specific monograph, and was therefore successfully implemented to assess samples manufactured by Nuclear Technology Development Center (CDTN).
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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