An efficient, sensitive spectrophotometric method has been developed and validated for the determination of bromhexine hydrochloride (BRH), in bulk drug and its pharmaceutical formulations. The method is based on the formation of Schiff Base with paradiethylamminobenzaldehyde (PDEAB) the reaction of drug with reagent gives a bright yellow colour. The so formed coloured species absorbance was measured at its absorption maximum (κmax) 425 nm. The Beer?s law has been obeyed in the concentration range 2-20 μ g/mL. The optical parameters were calculated as 2.42918x104 L/mol/cm, 0.016985 μ g/cm2, molar absorptivity and Sandell?s sensitivity respectively. The LOD and LOQ of the proposed method were calculated 0.2011 μ g/mL, 0.6696 μ g/mL respectively. All the variables were studied to optimize the reaction conditions. No interference was observed in the presence of common pharmaceutical excipients. The validity of the method was tested by analyzing BRH in its pharmaceutical formulations and critically tested for its accuracy by statistical tests. Good recoveries were obtained by the developed method; the obtained results were critically analyzed and successfully employed for the determination of BRH in its pharmaceutical dosage forms.
Bromhexine, PDEAB, Spectrophotometry, Mucolytic agent, Schiff base, Validation