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Quantification of Pomalidomide Using Conventional and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of Validation Parameters
[Image: see text] High-performance thin-layer chromatographic (HPTLC) assays for pomalidomide (PMD) measurement are lacking in the published database. Furthermore, eco-friendly stability-indicating analytical assays for PMD measurement are also lacking in the published database. In order to detect P...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Chemical Society
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10448633/ https://www.ncbi.nlm.nih.gov/pubmed/37636909 http://dx.doi.org/10.1021/acsomega.3c04382 |
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author | Alam, Prawez Shakeel, Faiyaz Iqbal, Muzaffar Foudah, Ahmed I. Alqarni, Mohammed H. Aljarba, Tariq M. Abdel Bar, Fatma Alshehri, Sultan |
author_facet | Alam, Prawez Shakeel, Faiyaz Iqbal, Muzaffar Foudah, Ahmed I. Alqarni, Mohammed H. Aljarba, Tariq M. Abdel Bar, Fatma Alshehri, Sultan |
author_sort | Alam, Prawez |
collection | PubMed |
description | [Image: see text] High-performance thin-layer chromatographic (HPTLC) assays for pomalidomide (PMD) measurement are lacking in the published database. Furthermore, eco-friendly stability-indicating analytical assays for PMD measurement are also lacking in the published database. In order to detect PMD in commercial products more accurately and sustainably than the conventional normal-phase HPTLC (NP-HPTLC) assay, an effort was made to design and verify a sensitive and eco-friendly reversed-phase HPTLC (RP-HPTLC) assay. The silica gel 60 NP-18F254S and 60 RP-18F254S plates were used as the stationary phases for NP-HPTLC and RP-HPTLC methods, respectively. The solvent system for NP-HPTLC was chloroform–methanol (90:10 v/v). However, the solvent system for RP-HPTLC was ethanol–water (75:25 v/v). The greenness scores for both assays were measured by AGREE approach. PMD measurement was performed for both assays at 372 nm. In the 50–600 and 20–1000 ng/band ranges, the NP-HPTLC and RP-HPTLC methods were linear for PMD measurement. The RP-HPTLC assay was superior to the NP-HPTLC method for measuring PMD in terms of sensitivity, accuracy, precision, and robustness. The ability of both methods to identify PMD in the presence of its degradation products suggests that both methods have stability-indicating features. When employing the NP-HPTLC and RP-HPTLC assays, respectively, the assay for PMD in commercial capsules was 88.68 and 98.83%. The AGREE scores for NP-HPTLC and RP-HPTLC assays were calculated to be 0.44 and 0.82, respectively, suggesting an outstanding greenness characteristic of the RP-HPTLC method than the NP-HPTLC method. The RP-HPTLC method was found to be superior to the NP-HPTLC method based on these findings. Therefore, the RP-HPTLC method could be successfully applied for the determination of PMD in pharmaceutical products. |
format | Online Article Text |
id | pubmed-10448633 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | American Chemical Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-104486332023-08-25 Quantification of Pomalidomide Using Conventional and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of Validation Parameters Alam, Prawez Shakeel, Faiyaz Iqbal, Muzaffar Foudah, Ahmed I. Alqarni, Mohammed H. Aljarba, Tariq M. Abdel Bar, Fatma Alshehri, Sultan ACS Omega [Image: see text] High-performance thin-layer chromatographic (HPTLC) assays for pomalidomide (PMD) measurement are lacking in the published database. Furthermore, eco-friendly stability-indicating analytical assays for PMD measurement are also lacking in the published database. In order to detect PMD in commercial products more accurately and sustainably than the conventional normal-phase HPTLC (NP-HPTLC) assay, an effort was made to design and verify a sensitive and eco-friendly reversed-phase HPTLC (RP-HPTLC) assay. The silica gel 60 NP-18F254S and 60 RP-18F254S plates were used as the stationary phases for NP-HPTLC and RP-HPTLC methods, respectively. The solvent system for NP-HPTLC was chloroform–methanol (90:10 v/v). However, the solvent system for RP-HPTLC was ethanol–water (75:25 v/v). The greenness scores for both assays were measured by AGREE approach. PMD measurement was performed for both assays at 372 nm. In the 50–600 and 20–1000 ng/band ranges, the NP-HPTLC and RP-HPTLC methods were linear for PMD measurement. The RP-HPTLC assay was superior to the NP-HPTLC method for measuring PMD in terms of sensitivity, accuracy, precision, and robustness. The ability of both methods to identify PMD in the presence of its degradation products suggests that both methods have stability-indicating features. When employing the NP-HPTLC and RP-HPTLC assays, respectively, the assay for PMD in commercial capsules was 88.68 and 98.83%. The AGREE scores for NP-HPTLC and RP-HPTLC assays were calculated to be 0.44 and 0.82, respectively, suggesting an outstanding greenness characteristic of the RP-HPTLC method than the NP-HPTLC method. The RP-HPTLC method was found to be superior to the NP-HPTLC method based on these findings. Therefore, the RP-HPTLC method could be successfully applied for the determination of PMD in pharmaceutical products. American Chemical Society 2023-08-07 /pmc/articles/PMC10448633/ /pubmed/37636909 http://dx.doi.org/10.1021/acsomega.3c04382 Text en © 2023 The Authors. Published by American Chemical Society https://creativecommons.org/licenses/by-nc-nd/4.0/Permits non-commercial access and re-use, provided that author attribution and integrity are maintained; but does not permit creation of adaptations or other derivative works (https://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Alam, Prawez Shakeel, Faiyaz Iqbal, Muzaffar Foudah, Ahmed I. Alqarni, Mohammed H. Aljarba, Tariq M. Abdel Bar, Fatma Alshehri, Sultan Quantification of Pomalidomide Using Conventional and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of Validation Parameters |
title | Quantification
of Pomalidomide Using Conventional
and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of
Validation Parameters |
title_full | Quantification
of Pomalidomide Using Conventional
and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of
Validation Parameters |
title_fullStr | Quantification
of Pomalidomide Using Conventional
and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of
Validation Parameters |
title_full_unstemmed | Quantification
of Pomalidomide Using Conventional
and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of
Validation Parameters |
title_short | Quantification
of Pomalidomide Using Conventional
and Eco-Friendly Stability-Indicating HPTLC Assays: A Contrast of
Validation Parameters |
title_sort | quantification
of pomalidomide using conventional
and eco-friendly stability-indicating hptlc assays: a contrast of
validation parameters |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10448633/ https://www.ncbi.nlm.nih.gov/pubmed/37636909 http://dx.doi.org/10.1021/acsomega.3c04382 |
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