A validated high performance liquid chromatographic method for estimation of bromhexine and terbutaline in bulk and tablet dosage forms

Introduction: Bromhexine (BH) is a mucolytic agent used in the treatment of respiratory disorders marketed in combination with terbutaline (TB), a β2-adrenergic receptor agonist used as a fast-acting bronchodilator. Materials and Methods: BH and TB were estimated at 270 nm by using ODS C8 column (length 250 mm and internal diameter 4.6 mm) as a stationary phase and a premix of phosphate buffer (0.05 M, pH 3): Acetonitrile (70:30 v/v) as a mobile phase. The total run time of this method was less than 20 min and the retention time for BH was found to be at 15.50 min while that of TB was 9.85 min at a flow rate of 1.0 ml/min, respectively. Results: Percentage label claim of tablet formulation using this method was found to be 99.35% for BH and 99.70% for TB, respectively. The standard deviation was found to be 0.225-0.351 for BH and 0.0.236-0.264 for TB for two different batches of tablet formulation. Conclusion: The results of analysis of two drugs from their tablet formulation using a developed method were found close to 100%. The low values of standard deviation indicate accuracy and reproducibility of the method. Thus developed methods can be used for the routine analysis of two drugs from a combined dosage form.