ABSTRACT:
Context: Ambroxol Hcl is an active metabolite of bromohexine. It is an expectoration improver and a mucolytic agent used in the treatment of bronchial asthma and chronic bronchitis.The available formulation of Ambroxol was authorized first in market since 1978.Objective: This article highlights on published analytical methods reported in the literature for the determination of Ambroxol HCl in biological samples and pharmaceutical formulations. Material and Methods: Various techniques like electrochemical, spectrophotometry, high-performance liquid chromatography (HPLC), liquid chromatography–mass spectrometry (LC–MS), Gas chromatography, Ultra performance liquid chromatography (UPLC) and high-performance thin layer chromatography (HPTLC) were used for the qualitative and quantitative estimation of Ambroxol HCl. Result and Discussion: Literature reveals that most widely used diluents are methanol and distilled water in HPLC methods, which prolonged the run times with greater tailing factor. For spectrometric determination, the presence of multiple entities and excipients includes complexity with multi- component dosage forms, which could produce significant challenge to the analytical chemist during the development of assay procedure. For such instances, chemo-metric methods can be preferred to routine spectrophotometric methods. Conclusion: Amongst various analytical techniques available for the quantification of single and multicomponent dosage form. HPLC methods are most extensively used for analysis of Ambroxol HCl.