Assay of bromhexine hydrochloride in pharmaceutical formulations by extraction spectrophotometry

Three simple and sensitive spectrophotometric methods (A-C) for the assay of bromhexine hydrochloride in pure and dosage forms based on the formation of chloroform soluble ion-associates under specified experimental conditions are described. Three acidic dyes, namely, Tropaeolin oo (TP oo, method A), Naphthalene blue 12BR (NB 12BR, method B) and Azocarmine G (ACG, method C) are utilized. The extracts of the ion-associates exhibit absorption maxima at 420, 620 and 540 nm for methods A, B and C respectively. Regression analysis of Beer-Lambert plots showed good correlation in the concentration ranges (2.0-10) μg/mL for method A, (5.0-25) μg/mL for methods B and C respectively. Beer’s law and the precision and accuracy of the methods are checked by the UV reference method. The results are reproducible with an accuracy of ± 1.0%. The methods are found to be suitable for the determination of bromhexine hydrochloride in the presence of the other ingredients that are usually present in dosage forms.