Original Articles: 2015 Vol: 7 Issue: 2
Simultaneous determination of Ambroxal hydrochloride and Salbutamol Sulphate in pharmaceutical dosage by reverse phase high performance liquid chromatography
Abstract
A simple, rapid and accurate high performance liquid chromatography method is described for simultaneous determination of ambroxal hydrochloride and salbutamol sulphate from active pharmaceutical ingredients. The separation of drug was achieved on Zorbax Eclipse C18 (250 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 (75:25 % v/v). The buffer was mixtures of 0.1 % (v/v) tri-ethyl amine solution adjusted the pH 3.5 with ortho-phosphoric acid. The detection was carried out at wavelength 230 nm. The mixture of buffer of pH 3.5 and acetonitrile (75:25% 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.