Reverse phase high performance liquid chromatography method for simultaneous determination of ambroxal hydrochloride, guaiphenesin and salbutamol sulphate from pharmaceutical dosage form

Rajan V. Rele and Swapnil A. S

Abstract

A simple, economical and accurate high performance liquid chromatography method is described for simultaneous determination of ambroxal hydrochloride, guaiphenesin and salbutamol sulphate from active pharmaceutical ingredients and dosage form. The separation of drugs were achieved on Hypersil quest 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 of pH 3.0 and acetonitrile [75:25 % (v/v)]. The detection was carried out at wavelength 225 nm. The mixture of buffer of pH 3.0 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, guaiphenesin and salbutamol sulphate from combined pharmaceutical dosage form.