Development and validation of an HPLC method for the simultaneous estimation of salbutamol, theophylline and ambroxol in tablet dosage form

Abstract

A simple, accurate and precise reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous estimation of Salbutamol, Theophylline and Ambroxol in pharmaceutical formulations. The chromatographic separation was achieved on a Inertsil ODS-3V (250 × 4.6 mm, 5μ) column using a mobile phase consisting of phosphate buffer (pH 3.0): acetonitrile in the ratio of 55:45 v/v at a flow rate of 1 mL/min. Detection was carried out at 225 nm. The retention times for Salbutamol, Theophylline and Ambroxol were found to be 2.317, 3.808 and 5.863 min respectively. The proposed method was validated as per the ICH guidelines and was found to be linear in the concentration range of 0.5-3.0 μg/mL, 25-150 μg/mL and 7.5-45 μg/mL for Salbutamol, Theophylline and Ambroxol respectively with correlation coefficients greater than 0.999. The developed method was found to be precise, accurate, robust and specific. Forced degradation studies proved the stability-indicating capability of the developed HPLC method. The developed method can be successfully applied for the routine analysis of Salbutamol, Theophylline and Ambroxol in pharmaceutical dosage forms.