Spectrophotometric Determination of Bromhexine Hydrochloride in Pharmaceutical Formulation Using Ion-Pair Complexation with Alizarin Red S
Keywords:
Bromhexine, Ion-pair complex, Spectrophotometry, Pharmaceutical analysis, Alizarin Red SAbstract
Background: Bromhexine hydrochloride is a synthetic mucolytic agent that has gained wide prescription for respiratory diseases, under which chronic bronchitis, asthma, and chronic obstructive pulmonary disease occur. Several analytical techniques have been reported for BRH determination include titrimetric, spectrophotometric, chromatographic, and electrochemical approaches. However, some involve complex instrumentation, skilled labor, and expensive consumables to run the assays thereby limiting their availability for routine quality control applications particularly in resource-limited laboratories.
Objective: To develop simple, sensitive and specific determination method for bromhexine hydrochloride in bulk and pharmaceutical formulations.
Methods: A simple, rapid, and accurate method of spectrophotometry was developed that is specific for the quantitative measurement of bromhexine hydrochloride (BRH) in bulk and pharmaceutical formulations. The method involves the creation of a stable complex between BRH and Alizarin Red S that exhibits the greatest absorption at 470nm. experimental variables, including the concentration of the dye, the pH of the solution, the temperature of the solution, and the length of the reaction, were systematically altered in order to increase the sensitivity and stability of the complex.
Results: Under the best conditions, the calibration graph exhibited a high degree of linearity over the concentration range of 30-100 µg/mL with a correlation coefficient of R² = 0.999. The method demonstrated a high degree of sensitivity, with a LOD of 0.375 µg/mL and a LQ of 1.137 µg/mL. Validation studies demonstrated that the accuracy was high (recoveries of 98-102%) and the precision was low (RSD < 3%). The proposed methodology was successful in the analysis of a commercial pharmaceutical preparation with a high concentration of ibuprofen (Solvodin syrup, SDI Samarra, Iraq), which yielded recovery values that were in close agreement with the labelled claims. The method of Job's was employed to assess the stoichiometric ratio between BRH and Alizarin Red S. Other spectrophotometric methods were compared with this approach, which had the benefits of being simple, cost-effective, and minimalistic in sample preparation, making it ideal for routine pharmaceutical quality control.
Conclusion: The developed method was simple and cost effective.
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