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Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma

BACKGROUND: Ritonavir was recently combined with nirmatrelvir in a new approved co-packaged medication form for the treatment of COVID-19. Quantitative analysis based on fluorescence spectroscopy measurement was extensively used for sensitive determination of compounds exhibited unique fluorescence...

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Autores principales: Imam, Mohamed S., Abdelazim, Ahmed H., Ramzy, Sherif, Almrasy, Ahmed A., Gamal, Mohammed, Batubara, Afnan S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10514966/
https://www.ncbi.nlm.nih.gov/pubmed/37735663
http://dx.doi.org/10.1186/s13065-023-01030-0
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author Imam, Mohamed S.
Abdelazim, Ahmed H.
Ramzy, Sherif
Almrasy, Ahmed A.
Gamal, Mohammed
Batubara, Afnan S.
author_facet Imam, Mohamed S.
Abdelazim, Ahmed H.
Ramzy, Sherif
Almrasy, Ahmed A.
Gamal, Mohammed
Batubara, Afnan S.
author_sort Imam, Mohamed S.
collection PubMed
description BACKGROUND: Ritonavir was recently combined with nirmatrelvir in a new approved co-packaged medication form for the treatment of COVID-19. Quantitative analysis based on fluorescence spectroscopy measurement was extensively used for sensitive determination of compounds exhibited unique fluorescence features. OBJECTIVE: The main objective of this work was to develop higher sensitive cost effective spectrofluorometric method for selective determination of ritonavir in the presence of nirmatrelvir in pure form, pharmaceutical tablet as well as in spiked human plasma. METHODS: Ritonavir was found to exhibit unique native emission fluorescence at 404 nm when excited at 326 nm. On the other hand, nirmatrelvir had no emission bands when excited at 326 nm. This feature allowed selective determination of ritonavir without any interference from nirmatrelvir. The variables affecting fluorescence intensity of ritonavir were optimized in terms of sensitivity parameters and principles of green analytical chemistry. Ethanol was used a green solvent which provided efficient fluorescence intensity of the cited drug. RESULTS: The method was validated in accordance with the ICH Q2 (R1) standards in terms of linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and specificity. The described method was successfully applied for ritonavir assay over the concentration range of 2.0–20.0 ng/mL. CONCLUSION: Ritonavir determination in the spiked human plasma was successfully done with satisfactory accepted results.
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spelling pubmed-105149662023-09-23 Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma Imam, Mohamed S. Abdelazim, Ahmed H. Ramzy, Sherif Almrasy, Ahmed A. Gamal, Mohammed Batubara, Afnan S. BMC Chem Research BACKGROUND: Ritonavir was recently combined with nirmatrelvir in a new approved co-packaged medication form for the treatment of COVID-19. Quantitative analysis based on fluorescence spectroscopy measurement was extensively used for sensitive determination of compounds exhibited unique fluorescence features. OBJECTIVE: The main objective of this work was to develop higher sensitive cost effective spectrofluorometric method for selective determination of ritonavir in the presence of nirmatrelvir in pure form, pharmaceutical tablet as well as in spiked human plasma. METHODS: Ritonavir was found to exhibit unique native emission fluorescence at 404 nm when excited at 326 nm. On the other hand, nirmatrelvir had no emission bands when excited at 326 nm. This feature allowed selective determination of ritonavir without any interference from nirmatrelvir. The variables affecting fluorescence intensity of ritonavir were optimized in terms of sensitivity parameters and principles of green analytical chemistry. Ethanol was used a green solvent which provided efficient fluorescence intensity of the cited drug. RESULTS: The method was validated in accordance with the ICH Q2 (R1) standards in terms of linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and specificity. The described method was successfully applied for ritonavir assay over the concentration range of 2.0–20.0 ng/mL. CONCLUSION: Ritonavir determination in the spiked human plasma was successfully done with satisfactory accepted results. Springer International Publishing 2023-09-21 /pmc/articles/PMC10514966/ /pubmed/37735663 http://dx.doi.org/10.1186/s13065-023-01030-0 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Imam, Mohamed S.
Abdelazim, Ahmed H.
Ramzy, Sherif
Almrasy, Ahmed A.
Gamal, Mohammed
Batubara, Afnan S.
Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma
title Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma
title_full Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma
title_fullStr Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma
title_full_unstemmed Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma
title_short Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma
title_sort higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new fda approved co-packaged covid-19 pharmaceutical dosage and spiked human plasma
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10514966/
https://www.ncbi.nlm.nih.gov/pubmed/37735663
http://dx.doi.org/10.1186/s13065-023-01030-0
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