Facile approaches for determination of Bromhexine Hydrochloride and its active metabolite Ambroxol Hydrochloride using Eosin Y.

A El-Sayed, H Elmansi, S Shalan, M Eid

Annales pharmaceutiques francaises 2022 Sep

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New validated Spectroscopic methods were developed to assay Bromhexine Hydrochloride and its active metabolite Ambroxol Hydrochloride separately in pure form and pharmaceutical formulations. The spectrophotometric assay (method I) shows complex formation between each of the drugs and Eosin Y at 540nm at pH 3.6 and 3.4mL of 4×10-4M Eosin for Bromhexine and Ambroxol. The Spectrofluorimetric assay (method II) depends on quenching eosin native fluorescence by the studied drugs, which measured at 540nm after excitation at 302nm. The spectrophotometric absorbance-concentration plot is rectilinear over the ranges (1.0-5.0) and (1.0-10.0) μg/mL for bromhexine and ambroxol with LOD of 0.31 and 0.14μg/mL and LOQ of 0.94 and 0.42μg/mL for the two drugs respectively. The fluorometric-concentration plot is linear along the range (1.0-5.0) μg/mL and (1-10) μg/mL for the two drugs respectively with LOD of 0.13μg/mL and 0.22μg/mL and LOQ of 0.4μg/mL and 0.65μg/mL for the two drugs, respectively. Developed assays have been validated in agreement with ICH recommendations and they were used in the analysis of commercial drug formulations containing the two mucolytic drugs and the results were matching with those obtained by the comparison method. Copyright © 2021 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Citation

A El-Sayed, H Elmansi, S Shalan, M Eid. Facile approaches for determination of Bromhexine Hydrochloride and its active metabolite Ambroxol Hydrochloride using Eosin Y. Annales pharmaceutiques francaises. 2022 Sep;80(5):687-696