Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Alam, Prawez, Shakeel, Faiyaz, Iqbal, Muzaffar, Foudah, Ahmed I., Alqarni, Mohammed H., Aljarba, Tariq M., Abdel Bar, Fatma, Alshehri, Sultan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Chemical Society 2023
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
_version_ 1785094776398282752
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
work_keys_str_mv AT alamprawez quantificationofpomalidomideusingconventionalandecofriendlystabilityindicatinghptlcassaysacontrastofvalidationparameters
AT shakeelfaiyaz quantificationofpomalidomideusingconventionalandecofriendlystabilityindicatinghptlcassaysacontrastofvalidationparameters
AT iqbalmuzaffar quantificationofpomalidomideusingconventionalandecofriendlystabilityindicatinghptlcassaysacontrastofvalidationparameters
AT foudahahmedi quantificationofpomalidomideusingconventionalandecofriendlystabilityindicatinghptlcassaysacontrastofvalidationparameters
AT alqarnimohammedh quantificationofpomalidomideusingconventionalandecofriendlystabilityindicatinghptlcassaysacontrastofvalidationparameters
AT aljarbatariqm quantificationofpomalidomideusingconventionalandecofriendlystabilityindicatinghptlcassaysacontrastofvalidationparameters
AT abdelbarfatma quantificationofpomalidomideusingconventionalandecofriendlystabilityindicatinghptlcassaysacontrastofvalidationparameters
AT alshehrisultan quantificationofpomalidomideusingconventionalandecofriendlystabilityindicatinghptlcassaysacontrastofvalidationparameters