Green chemistry approaches in the analytical validation of fosravuconazole using UV spectrophotometry and HPLC

Fosravuconazole, a newly developed oral antifungal medication by Eisai, has been utilized since 2018 for the treatment of tinea unguium. Its notable characteristics include high oral absorption and systemic bioavailability, which allow for a brief treatment duration of 3 months. Its mild inhibition...

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Main Authors: Jeswin Maliyakal, Mital Patel
Format: Article
Language:English
Published: Elsevier 2025-03-01
Series:Green Analytical Chemistry
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Online Access:http://www.sciencedirect.com/science/article/pii/S2772577425000126
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author Jeswin Maliyakal
Mital Patel
author_facet Jeswin Maliyakal
Mital Patel
author_sort Jeswin Maliyakal
collection DOAJ
description Fosravuconazole, a newly developed oral antifungal medication by Eisai, has been utilized since 2018 for the treatment of tinea unguium. Its notable characteristics include high oral absorption and systemic bioavailability, which allow for a brief treatment duration of 3 months. Its mild inhibition of the cytochrome P450 enzyme, which plays a role in adverse effects during polypharmacy, allows for the safe use of fosravuconazole alongside other medications, making it suitable for elderly patients. This study addresses the need for a precise quantitative method to determine “Fosravuconazole” using UV spectrophotometry and High-Performance Liquid Chromatography (HPLC). The HPLC method used an isocratic approach with a reversed-phase CHROMASIL C18 column (4.6 mm × 250 mm, 5 µm), a flow rate of 0.9 mL/min and detection at a wavelength of 287 nm. The mobile phase was a mixture of Acetonitrile and a 10 mM Ammonium Acetate buffer at pH 4.5, with the pH adjusted using acetic acid. Both methods were rigorously validated according to ICH Q2(R1) guidelines, demonstrating their suitability for the assessment of individual substances in various mixtures. To evaluate their environmental impact, AGREE, GAPI, and BAGI were used to evaluate the methods highlighting their sustainability in terms of solvent consumption, chemical and energy use, waste generation. BAGI showed that both methods possess scores above the recommended threshold score of 60, qualifying them for industrial applications. The UV method demonstrated a greener profile compared to the HPLC method.
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series Green Analytical Chemistry
spelling doaj-art-4ad6e4d421ad41939728f0a7ba052e7e2025-02-05T04:32:51ZengElsevierGreen Analytical Chemistry2772-57742025-03-0112100215Green chemistry approaches in the analytical validation of fosravuconazole using UV spectrophotometry and HPLCJeswin Maliyakal0Mital Patel1Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKMs NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai, Maharashtra 400056, IndiaCorresponding author.; Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKMs NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai, Maharashtra 400056, IndiaFosravuconazole, a newly developed oral antifungal medication by Eisai, has been utilized since 2018 for the treatment of tinea unguium. Its notable characteristics include high oral absorption and systemic bioavailability, which allow for a brief treatment duration of 3 months. Its mild inhibition of the cytochrome P450 enzyme, which plays a role in adverse effects during polypharmacy, allows for the safe use of fosravuconazole alongside other medications, making it suitable for elderly patients. This study addresses the need for a precise quantitative method to determine “Fosravuconazole” using UV spectrophotometry and High-Performance Liquid Chromatography (HPLC). The HPLC method used an isocratic approach with a reversed-phase CHROMASIL C18 column (4.6 mm × 250 mm, 5 µm), a flow rate of 0.9 mL/min and detection at a wavelength of 287 nm. The mobile phase was a mixture of Acetonitrile and a 10 mM Ammonium Acetate buffer at pH 4.5, with the pH adjusted using acetic acid. Both methods were rigorously validated according to ICH Q2(R1) guidelines, demonstrating their suitability for the assessment of individual substances in various mixtures. To evaluate their environmental impact, AGREE, GAPI, and BAGI were used to evaluate the methods highlighting their sustainability in terms of solvent consumption, chemical and energy use, waste generation. BAGI showed that both methods possess scores above the recommended threshold score of 60, qualifying them for industrial applications. The UV method demonstrated a greener profile compared to the HPLC method.http://www.sciencedirect.com/science/article/pii/S2772577425000126SustainabilityBluenessFosravuconazoleAGREEComplex GAPIGreen chemistry
spellingShingle Jeswin Maliyakal
Mital Patel
Green chemistry approaches in the analytical validation of fosravuconazole using UV spectrophotometry and HPLC
Green Analytical Chemistry
Sustainability
Blueness
Fosravuconazole
AGREE
Complex GAPI
Green chemistry
title Green chemistry approaches in the analytical validation of fosravuconazole using UV spectrophotometry and HPLC
title_full Green chemistry approaches in the analytical validation of fosravuconazole using UV spectrophotometry and HPLC
title_fullStr Green chemistry approaches in the analytical validation of fosravuconazole using UV spectrophotometry and HPLC
title_full_unstemmed Green chemistry approaches in the analytical validation of fosravuconazole using UV spectrophotometry and HPLC
title_short Green chemistry approaches in the analytical validation of fosravuconazole using UV spectrophotometry and HPLC
title_sort green chemistry approaches in the analytical validation of fosravuconazole using uv spectrophotometry and hplc
topic Sustainability
Blueness
Fosravuconazole
AGREE
Complex GAPI
Green chemistry
url http://www.sciencedirect.com/science/article/pii/S2772577425000126
work_keys_str_mv AT jeswinmaliyakal greenchemistryapproachesintheanalyticalvalidationoffosravuconazoleusinguvspectrophotometryandhplc
AT mitalpatel greenchemistryapproachesintheanalyticalvalidationoffosravuconazoleusinguvspectrophotometryandhplc