Indirect spectrophotometric method for determination of bromhexine-HCl in pharmaceutical preparations

Abstract EN

A simple, accurate and sensitive spectrophotometric method for determination of bromhexine- HCl in aqueous solution has been described.

The proposed method is based on the reduction of cerium (Іν) in acidic medium into cerium (Ш) by the drug followed by the complex formation of cerium (Ш) with arsenazo Ш to form a greenish-blue water soluble, stable complex that has a maximum absorbance at 651nm against the reagent blank.

Beer’s law is obeyed in the range of 10 to 200μg of bromhexine-HCl /20 ml (i.e.

0.5-10 ppm) with molar absorptivity of 1.48×104 l.mol-1.

cm-1 and a good determination coefficient (R2=0.9978).

The limit of detection (LOD) and limit of quantification (LOQ) are 0.408 and 1.394μg ml−1, respectively.

The relative error and a relative standard deviations are found in the range -0.354 to1.93 % and ± 0.135 to ± 1.033%, respectively, depending on the conc-entration level.

The method is suitable for the determination of bromhexine- HCl in the presence of other ingredients that are usually present in dosage forms.

This procedure is applied successfully for the analysis of bromhexine-HCl in pharmaceutical preparations (tablets, syrup and injection) without prior separation and with acceptable errors.