Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples
In this study, an environmentally friendly “high-performance liquid chromatography (HPLC)” assay to quantify isotretinoin (ITN) in commercial products and solubility samples is designed and verified. A Nucleodur reverse-phase C18 column was used as the stationary phase to identify ITN. The ecologica...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-08-01
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| Series: | Heliyon |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S240584402305613X |
| _version_ | 1797733066561552384 |
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| author | Nazrul Haq Sultan Alshehri Ibrahim A. Alsarra Miteb Alenazi Abdulrahman Alwhaibi Faiyaz Shakeel |
| author_facet | Nazrul Haq Sultan Alshehri Ibrahim A. Alsarra Miteb Alenazi Abdulrahman Alwhaibi Faiyaz Shakeel |
| author_sort | Nazrul Haq |
| collection | DOAJ |
| description | In this study, an environmentally friendly “high-performance liquid chromatography (HPLC)” assay to quantify isotretinoin (ITN) in commercial products and solubility samples is designed and verified. A Nucleodur reverse-phase C18 column was used as the stationary phase to identify ITN. The ecologically friendly mobile phase was composed of ethyl acetate and ethanol (50:50 v/v), and it was delivered at a flow rate of 1.0 mL/min. ITN was measured at 354 nm in wavelength. The current HPLC method had a determination coefficient of 0.9994 and was linear in the 0.2–80 μg/g range. The current protocol for ITN measurement was also rapid (retention time = 2.78 min), accurate (%recoveries = 98.60–101.52), precise (% uncertainties = 0.71–0.98), and sensitive. According to the AGREE methodology, the current procedure received an outstanding greenness profile with an AGREE score of 0.76. By determining ITN in commercial products and solubility samples, the applicability of the current approach was proven. ITN was discovered to be present in 98.43% and 100.84%, respectively, of commercial capsule brands A and B. The ITN's solubility in numerous eco-friendly solvents was successfully measured. Under different stress conditions, the current approach was able to distinguish between its degradation products, demonstrating its stability-indicating characteristics. These findings indicated that ITN in procured capsules and solubility samples might be regularly tested by the suggested approach. |
| first_indexed | 2024-03-12T12:22:34Z |
| format | Article |
| id | doaj.art-660373ec4a8740d09677d83b6cfb6b0d |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-03-12T12:22:34Z |
| publishDate | 2023-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-660373ec4a8740d09677d83b6cfb6b0d2023-08-30T05:51:13ZengElsevierHeliyon2405-84402023-08-0198e18405Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samplesNazrul Haq0Sultan Alshehri1Ibrahim A. Alsarra2Miteb Alenazi3Abdulrahman Alwhaibi4Faiyaz Shakeel5Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia; Corresponding author.In this study, an environmentally friendly “high-performance liquid chromatography (HPLC)” assay to quantify isotretinoin (ITN) in commercial products and solubility samples is designed and verified. A Nucleodur reverse-phase C18 column was used as the stationary phase to identify ITN. The ecologically friendly mobile phase was composed of ethyl acetate and ethanol (50:50 v/v), and it was delivered at a flow rate of 1.0 mL/min. ITN was measured at 354 nm in wavelength. The current HPLC method had a determination coefficient of 0.9994 and was linear in the 0.2–80 μg/g range. The current protocol for ITN measurement was also rapid (retention time = 2.78 min), accurate (%recoveries = 98.60–101.52), precise (% uncertainties = 0.71–0.98), and sensitive. According to the AGREE methodology, the current procedure received an outstanding greenness profile with an AGREE score of 0.76. By determining ITN in commercial products and solubility samples, the applicability of the current approach was proven. ITN was discovered to be present in 98.43% and 100.84%, respectively, of commercial capsule brands A and B. The ITN's solubility in numerous eco-friendly solvents was successfully measured. Under different stress conditions, the current approach was able to distinguish between its degradation products, demonstrating its stability-indicating characteristics. These findings indicated that ITN in procured capsules and solubility samples might be regularly tested by the suggested approach.http://www.sciencedirect.com/science/article/pii/S240584402305613XAGREEIsotretinoinEnvironmentally friendly HPLCSolubilityValidation |
| spellingShingle | Nazrul Haq Sultan Alshehri Ibrahim A. Alsarra Miteb Alenazi Abdulrahman Alwhaibi Faiyaz Shakeel Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples Heliyon AGREE Isotretinoin Environmentally friendly HPLC Solubility Validation |
| title | Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples |
| title_full | Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples |
| title_fullStr | Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples |
| title_full_unstemmed | Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples |
| title_short | Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples |
| title_sort | environmentally friendly stability indicating hplc method for the determination of isotretinoin in commercial products and solubility samples |
| topic | AGREE Isotretinoin Environmentally friendly HPLC Solubility Validation |
| url | http://www.sciencedirect.com/science/article/pii/S240584402305613X |
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