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

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<sup>-1</sup>) with low detection limit 0.199 μg mL<sup>-1</sup> and low quantification limit 0.605 μg mL<sup>-1</sup>. 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.

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Publication Details

Journal
Scientific Reports
Published
2026-02-04
DOI
https://doi.org/10.1038/s41598-025-28360-4
Primary Topic
Dye analysis and toxicity
Type
article
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article

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

Salwa Kh. Mohamed, Mahmoud A. Omar, Deena A. Nour-Eldeen
Scientific Reports
Dye analysis and toxicity
article

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

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

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<sup>-1</sup>) with low detection limit 0.199 μg mL<sup>-1</sup> and low quantification limit 0.605 μg mL<sup>-1</sup>. 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.

Scientific ReportsVol. 16(1)
Taibah University (SA), Minia University (EG)
Openalex Percentile: Top 66%
Dye analysis and toxicity
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Development and validation of a green analytical method to determine bromhexine hydrochloride in pharmaceuticals — Salwa Kh. Mohamed, Mahmoud A. Omar, et al. · Scientific Reports (2026) | TGRS Research Map | TGRS