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Development and validation of a green analytical method to determine bromhexine hydrochloride in pharmaceuticals
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  • Published: 04 February 2026

Development and validation of a green analytical method to determine bromhexine hydrochloride in pharmaceuticals

  • Salwa Kh. Mohamed1,
  • Deena A. Nour-Eldeen1 &
  • Mahmoud A. Omar1,2 

Scientific Reports , Article number:  (2026) Cite this article

We are providing an unedited version of this manuscript to give early access to its findings. Before final publication, the manuscript will undergo further editing. Please note there may be errors present which affect the content, and all legal disclaimers apply.

Subjects

  • Analytical chemistry
  • Inorganic chemistry

Abstract

Erythrosine B (EB) is a food colorant and antiviral xanthene dye that is widely used as a color additive in pharmaceutical and cosmetic industries. Its application as a sensor for spectrophotometric measurement of amine-based pharmaceuticals offers several benefits due to its availability, low cost, quick labeling, and high sensitivity. In the present study, a quick, sensitive and simple green spectrophotometric method has been developed to assay Bromhexine Hydrochloride (BMH) in pure form and its pharmaceutical formulation. The spectrophotometric methodology reveals complex development between the drug and erythrosine B at 556 nm at pH 3.6. The spectrophotometric absorbance-concentration curve is linear over the ranges (1.0–9.0 μg mL−1) with low detection limit 0.199 μg mL−1 and low quantification limit 0.605 μg mL−1. The developed approach was assessed for linearity, accuracy, precision, limits of detection, and limits of quantitation in compliance with International Council for Harmonisation validation recommendations. Lastly, the suggested approach has been successfully implemented to quantify the cited medication colorimetrically in its dosage form with excellent recoveries. Also, the greenness of the suggested approach was measured by some of the recent green analytical measures as applications to our presented methodology show further access to this study.

Data availability

Data is provided within the manuscript or supplementary information file.

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Author information

Authors and Affiliations

  1. Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, 61511, Egypt

    Salwa Kh. Mohamed, Deena A. Nour-Eldeen & Mahmoud A. Omar

  2. Department of Pharmacognosy and Pharmaceutical Chemistry, College of Pharmacy, Taibah University, 41477, Al-Madinah Al-Munawwarah, Saudi Arabia

    Mahmoud A. Omar

Authors
  1. Salwa Kh. Mohamed
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  2. Deena A. Nour-Eldeen
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  3. Mahmoud A. Omar
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Contributions

Salwa Mohammed: Methodology, writing—original draft, validation, resources, investigation. Deena A. Nour-Eldeen: Software, resources, data curation. Mahmoud A. Omar: Writing—review and editing, validation, supervision.

Corresponding author

Correspondence to Mahmoud A. Omar.

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Mohamed, S.K., Nour-Eldeen, D.A. & Omar, M.A. Development and validation of a green analytical method to determine bromhexine hydrochloride in pharmaceuticals. Sci Rep (2026). https://doi.org/10.1038/s41598-025-28360-4

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  • Received: 06 April 2025

  • Accepted: 10 November 2025

  • Published: 04 February 2026

  • DOI: https://doi.org/10.1038/s41598-025-28360-4

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Keywords

  • Bromhexine hydrochloride
  • Erythrosine B
  • Spectrophotometric determination
  • White
  • Blue and green profile evaluation
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