Extractive Spectrophotometric Methods for Determination of Ambroxol Hydrochloride in Pharmaceutical Formulations Using Some Acidic Triphenylmethane Dyes

Three simple and sensitive extractive spectrophotometric methods have been described for the assay of Ambroxol hydrochloride either in pure form or in pharmaceutical formulations. The developed methods involve formation of coloured chloroform extractable ion-pair complexes of the drug with bromothymol blue (BTB), bromophenol blue (BPB) and bromocresol purple (BCP) in acidic medium. The extracted complexes showed absorbance maxima at 414, 412 and 407nm with use of the cited reagents, respectively. Beer's law is obeyed in the concentration ranges 2.5-25, 4.0-30 and 4.0-40μg/ml with BTB, BPB and BCP respectively. The effect of concentration of dye, pH, and interference of excipients have been studied and optimized. The limits of detection and quantification have been determined for three methods. All the three methods have been validated as per the guidelines of ICH. The methods have been applied to the determination of drug in commercial tablets and results of analysis were validated statistically through recovery studies.