Staff View: Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical

Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical

Objective: Analytical gas chromatography in line with a flame ionisation detector (GC-FID) method was developed and validated for evaluating organic solvents in radiopharmaceutical samples [18F]fluoroethyl-tyrosine ([18F]FET [18F] fluoromisonidazole ([18F]FMISO) and [18F] fluorothymidine ([18F]FLT)....

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Main Authors:	Hassan, Hishar, Othman, Muhamad Faiz, Zakaria, Zainul Amiruddin, Ahmad Saad, Fathinul Fikri, Abdul Razak, Hairil Rashmizal
Format:	Article
Published:	Elsevier 2021
Online Access:	http://psasir.upm.edu.my/id/eprint/94303/ https://www.sciencedirect.com/science/article/pii/S1018364721002159?via%3Dihub
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spelling	my.upm.eprints.943032023-05-08T03:06:07Z http://psasir.upm.edu.my/id/eprint/94303/ Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical Hassan, Hishar Othman, Muhamad Faiz Zakaria, Zainul Amiruddin Ahmad Saad, Fathinul Fikri Abdul Razak, Hairil Rashmizal Objective: Analytical gas chromatography in line with a flame ionisation detector (GC-FID) method was developed and validated for evaluating organic solvents in radiopharmaceutical samples [18F]fluoroethyl-tyrosine ([18F]FET [18F] fluoromisonidazole ([18F]FMISO) and [18F] fluorothymidine ([18F]FLT). Variables of the carrier gas flow (mL min-1 ) and a split ratio of injection on the response of analysis time and resolution were optimised with the assistance of a two-level full factorial design and desirability function of Derringer. Methods: The proposed procedure was validated following the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2 (R1) guideline. Results: Excellent linearity, R2 > 0.990 indicated that approximately 99% of the variance in the response could be predicted from ethanol and acetonitrile concentrations ranging from 0.8 to 7.5 mg mL-1 and 0.1 to 1.0 mg mL-1, respectively. The proposed procedure proved to be selective, sensitive and accurate (85 to 105%), with excellent repeatability and precision (relative standard deviation (RSD) < 2%). In assessing the robustness of the method, the proposed procedure also proved to be robust as the standardised effects values (SE) were insignificant (p > 0.05). Conclusion: The proposed method has also been successfully used for the quantitative determination of ethanol and acetonitrile in [18F]FET, [18F]FMISO and [18F]FLT samples. Analytes were well resolved (R, 7.9 – 8.1) within 3.5 min even though the column had a larger, 0.53 mm internal diameter. The proposed method is, therefore, relevant for routine organic solvent quality control analysis of any 18Fradiopharmaceutical derivatives. Elsevier 2021-09 Article PeerReviewed Hassan, Hishar and Othman, Muhamad Faiz and Zakaria, Zainul Amiruddin and Ahmad Saad, Fathinul Fikri and Abdul Razak, Hairil Rashmizal (2021) Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical. Journal of King Saud University – Science, 33 (6). art. no. 101554. pp. 1-9. ISSN 1018-3647; ESSN: 2213-686X https://www.sciencedirect.com/science/article/pii/S1018364721002159?via%3Dihub 10.1016/j.jksus.2021.101554
institution	Universiti Putra Malaysia
building	UPM Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Universiti Putra Malaysia
content_source	UPM Institutional Repository
url_provider	http://psasir.upm.edu.my/
description	Objective: Analytical gas chromatography in line with a flame ionisation detector (GC-FID) method was developed and validated for evaluating organic solvents in radiopharmaceutical samples [18F]fluoroethyl-tyrosine ([18F]FET [18F] fluoromisonidazole ([18F]FMISO) and [18F] fluorothymidine ([18F]FLT). Variables of the carrier gas flow (mL min-1 ) and a split ratio of injection on the response of analysis time and resolution were optimised with the assistance of a two-level full factorial design and desirability function of Derringer. Methods: The proposed procedure was validated following the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2 (R1) guideline. Results: Excellent linearity, R2 > 0.990 indicated that approximately 99% of the variance in the response could be predicted from ethanol and acetonitrile concentrations ranging from 0.8 to 7.5 mg mL-1 and 0.1 to 1.0 mg mL-1, respectively. The proposed procedure proved to be selective, sensitive and accurate (85 to 105%), with excellent repeatability and precision (relative standard deviation (RSD) < 2%). In assessing the robustness of the method, the proposed procedure also proved to be robust as the standardised effects values (SE) were insignificant (p > 0.05). Conclusion: The proposed method has also been successfully used for the quantitative determination of ethanol and acetonitrile in [18F]FET, [18F]FMISO and [18F]FLT samples. Analytes were well resolved (R, 7.9 – 8.1) within 3.5 min even though the column had a larger, 0.53 mm internal diameter. The proposed method is, therefore, relevant for routine organic solvent quality control analysis of any 18Fradiopharmaceutical derivatives.
format	Article
author	Hassan, Hishar Othman, Muhamad Faiz Zakaria, Zainul Amiruddin Ahmad Saad, Fathinul Fikri Abdul Razak, Hairil Rashmizal
spellingShingle	Hassan, Hishar Othman, Muhamad Faiz Zakaria, Zainul Amiruddin Ahmad Saad, Fathinul Fikri Abdul Razak, Hairil Rashmizal Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical
author_facet	Hassan, Hishar Othman, Muhamad Faiz Zakaria, Zainul Amiruddin Ahmad Saad, Fathinul Fikri Abdul Razak, Hairil Rashmizal
author_sort	Hassan, Hishar
title	Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical
title_short	Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical
title_full	Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical
title_fullStr	Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical
title_full_unstemmed	Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical
title_sort	multivariate optimisation and validation of the analytical gc-fid for evaluating organic solvents in radiopharmaceutical
publisher	Elsevier
publishDate	2021
url	http://psasir.upm.edu.my/id/eprint/94303/ https://www.sciencedirect.com/science/article/pii/S1018364721002159?via%3Dihub
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score	13.211869

Multivariate optimisation and validation of the analytical GC-FID for evaluating organic solvents in radiopharmaceutical

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