Quantification of Ambroxol Hydrochloride in Bulk and Oral Dosage Form using Spectrofluorimetry Method

Abstract

Ambroxol Hydrochloride is a widely used mucolytic agent in the pharmaceutical industry. Accurate quantification of Ambroxol Hydrochloride is crucial for quality control and assurance in both bulk drug substance and oral dosage forms. Spectrofluorimetry is a highly sensitive and selective analytical technique that offers significant advantages for this purpose. In this study, a validated spectrofluorimetry method was developed for the quantification of Ambroxol Hydrochloride in bulk and oral dosage form. The spectrofluorimetry method involved excitation and emission wavelengths at specific ranges suitable for Ambroxol Hydrochloride detection. Calibration curves were constructed to establish the relationship between the drug concentration and fluorescence intensity. The method exhibited a linear range of concentrations with excellent correlation coefficients. The limit of detection and limit of quantification were determined to evaluate the method's sensitivity. The developed method was successfully applied to quantify Ambroxol Hydrochloride in both bulk drug substance and commercial oral dosage forms. The results obtained were consistent, accurate. This method provides a rapid, cost-effective, and precise means of quantifying Ambroxol Hydrochloride in pharmaceutical samples, making it a valuable tool for quality control and formulation development. The high sensitivity and selectivity of spectrofluorimetry further enhance its utility for routine analysis of Ambroxol Hydrochloride in pharmaceutical laboratories.