Spectrophotometric Determination of Bromhexine Hydrochloride by Diazotization and Coupling Method in Its Pharmaceutical Preparations

Abstract

A simple, fast, and sensitive spectrophotometric method was suggested for the determination of Bromhexine Hydrochloride (BHH) in its pharmaceutical formulations. The method depends on the diazotization of BHH by sodium nitrite in acidic medium to produce the corresponding diazonium salt. The latter is coupled with phloroglucinol reagent in alkali medium to form a yellow water soluble azo-dye which has a maximum absorption at 405 nm with a molar absorptivity of 2.7×10⁴ l.mol^-1.cm^-1 and Sandellʼs sensitivity of 0.01517 µg.cm^-1. Beerʼs low is obeyed within a concentration range of 0.25-15 µg.mL^-1 of BHH. The LOD and LOQ values of the proposed method were 0.087 µg.mL^-1 and 0.293 µg.ml^-1, respectively. The proposed method was validated with standard methods and successfully applied to the determination of Bromhexine in its pharmaceutical formulations as tablets, syrup, and injections.