Stability-indicating method for the analysis of salbutamol and its pharmaceutical dosage forms by HPLC

Abstract

In this work, an ion-pair reversed phase HPLC method was developed for the determination of salbutamol sulphate and its degradation products which can be applied for the assay of tablet, injection and syrup. The separation of salbutamol was performed in 16minutes with high efficiency using ODS column 25cm and a mobile phase consists of methanol 30% and SLS 0.02%, adjusted with acetic acid to pH3.5. The accuracy and precision of this HPLC method was proved since a straight line relationship was obtained between the peak areas and the different concentrations of salbutamol sulphate standard in the range (0.1-0.8)mg/100ml water with confidence limit 0.998 and the RSD is not more than 1.1%. In addition, this method was found to be quiet suitable for stability work on salbutamol since, there is no interference between the peaks of degradation products and the peak of the parent compound.