SPECTROPHOTOMETRIC QUANTITATIVE DETERMINATION OF AMBROXOL HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS USING PDAB REAGENT

A simple, sensitive, cost-effective spectrophotometric method has been developed and validated for the determination of Ambroxol hydrochloride (AMB), in bulk drug and its pharmaceutical formulations. The method is based on the formation of a Schiff base with PDAB; the reaction of drug with reagent gives a bright yellow color. The so formed colored species absorbance was measured at its absorption maximum (λ_max) 423 nm. Beer’s law has been obeyed in the concentration range 5-30 µg/ml. The optical parameters were calculated as 2.0702 × 10⁴ (L/mol/cm), 0.0183 (µg/cm²), molar absorptivity and Sandell sensitivity respectively. The LOD and LOQ of the proposed method were calculated 0.0844 (μg/ml), 0.2812 (μg/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 AMB 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 AMB in its pharmaceutical dosage forms.