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Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry

Airsupra inhalation aerosol is a recently approved FDA medication that combines albuterol and budesonide for treating or preventing bronchoconstriction and lowering the risk of relapses in asthma patients who are 18 years of age and older. To selectively determine albuterol and budesonide in both pu...

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Autores principales: Almalki, Atiah H., Ramzy, Sherif, Almrasy, Ahmed A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10547681/
https://www.ncbi.nlm.nih.gov/pubmed/37789024
http://dx.doi.org/10.1038/s41598-023-42766-y
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author Almalki, Atiah H.
Ramzy, Sherif
Almrasy, Ahmed A.
author_facet Almalki, Atiah H.
Ramzy, Sherif
Almrasy, Ahmed A.
author_sort Almalki, Atiah H.
collection PubMed
description Airsupra inhalation aerosol is a recently approved FDA medication that combines albuterol and budesonide for treating or preventing bronchoconstriction and lowering the risk of relapses in asthma patients who are 18 years of age and older. To selectively determine albuterol and budesonide in both pure and pharmaceutical dosage forms, two analytical methods were developed: the zero-order absorption method and the dual-wavelength method. Even though the two drugs absorption spectra overlapped, the distinctive peak of budesonide at the zero absorbance point of albuterol, 245 nm, allowed for direct detection of budesonide in the combination using the zero-order absorption method. The mathematical dual-wavelength method, on the other hand, allowed for the measurement of both albuterol and budesonide by choosing two wavelengths for each drug in such a way that the absorbance difference for the second drug was zero. Budesonide exhibited comparable absorbance values at wavelengths 227 and 261.40 nm; hence, these two wavelengths were utilized to identify albuterol; similarly, 221.40 and 231.20 nm were chosen to determine budesonide in their binary mixes. The methods were validated according to the ICH guideline for validation of analytical procedures Q2(R1) and demonstrated excellent linearity, sensitivity, accuracy, precision, and selectivity for determining both drugs in synthetic mixed solutions and pharmaceutical formulations. The availability of these analytical methods would be valuable for the pharmaceutical industry and regulatory authorities for quality control and assessment of pharmaceutical formulations containing albuterol and budesonide.
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spelling pubmed-105476812023-10-05 Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry Almalki, Atiah H. Ramzy, Sherif Almrasy, Ahmed A. Sci Rep Article Airsupra inhalation aerosol is a recently approved FDA medication that combines albuterol and budesonide for treating or preventing bronchoconstriction and lowering the risk of relapses in asthma patients who are 18 years of age and older. To selectively determine albuterol and budesonide in both pure and pharmaceutical dosage forms, two analytical methods were developed: the zero-order absorption method and the dual-wavelength method. Even though the two drugs absorption spectra overlapped, the distinctive peak of budesonide at the zero absorbance point of albuterol, 245 nm, allowed for direct detection of budesonide in the combination using the zero-order absorption method. The mathematical dual-wavelength method, on the other hand, allowed for the measurement of both albuterol and budesonide by choosing two wavelengths for each drug in such a way that the absorbance difference for the second drug was zero. Budesonide exhibited comparable absorbance values at wavelengths 227 and 261.40 nm; hence, these two wavelengths were utilized to identify albuterol; similarly, 221.40 and 231.20 nm were chosen to determine budesonide in their binary mixes. The methods were validated according to the ICH guideline for validation of analytical procedures Q2(R1) and demonstrated excellent linearity, sensitivity, accuracy, precision, and selectivity for determining both drugs in synthetic mixed solutions and pharmaceutical formulations. The availability of these analytical methods would be valuable for the pharmaceutical industry and regulatory authorities for quality control and assessment of pharmaceutical formulations containing albuterol and budesonide. Nature Publishing Group UK 2023-10-03 /pmc/articles/PMC10547681/ /pubmed/37789024 http://dx.doi.org/10.1038/s41598-023-42766-y 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/) .
spellingShingle Article
Almalki, Atiah H.
Ramzy, Sherif
Almrasy, Ahmed A.
Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry
title Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry
title_full Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry
title_fullStr Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry
title_full_unstemmed Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry
title_short Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry
title_sort development and validation of analytical methods for selective determination of albuterol and budesonide in airsupra inhalation aerosol using spectrophotometry
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10547681/
https://www.ncbi.nlm.nih.gov/pubmed/37789024
http://dx.doi.org/10.1038/s41598-023-42766-y
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