Abstract

A simple, rapid and accurate high performance liquid chromatography method is described for determination of ambroxal hydrochloride from active pharmaceutical ingredients. The separation of drug was achieved on BDS hypersil C18 (150 x 4.6 mm i.d.) with 5 µ particle size column showed most favorable chromatographic pattern over the other columns. The mobile phase consisted of a mixture of buffer and acetonitrile (70:30 % v/v). The buffer was mixtures of 0.1 % tri-ethyl amine solution adjusted the pH 4.0 with acetic acid. The detection was carried out at wavelength 250 nm. The mixture of buffer of pH 4 and acetonitrile (50:50% v/v) was used as a diluent. The method was validated for system suitability, linearity, accuracy, precision, robustness, stability of sample solution. The method has been successfully used to analyze ambroxal hydrochloride from active pharmaceutical ingredients.