Development and validation of a method of determining ambroxol hydrochloride and impurities in syrup with HPLC

Abstract

A method is developed for the quantitative analysis of ambroxol hydrochloride in dosage form as syrup with simultaneous determination of impurities by high-performance liquid chromatography with diode-array detection. Conditions of chromatographic separation in gradient elution mode are established. Validation of the developed method was carried out in terms of specificity with respect to solvent and placebo effects, as well as the influence of sodium benzoate. The limit of detection was 0.072 µg mL-1. Linearity was determined with eight values of concentration of ambroxol hydrochloride in solution. The accuracy and precision (repeatability, in-lab precision) of the method were also evaluated. The applicability of the method for quality control of drugs was demonstrated. The proposed method was included in the Pharmacopeia.