Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2013 Vol: 5 Issue: 11

Development and validation of RP HPLC PDA method for the simultaneous estimation of salbutamol sulphate and ambroxol hydrochloride in pharmaceutical dosage forms

Abstract

A simple, specific and accurate reverse phase liquid chromatographic method was developed for the simultaneous estimation of Salbutamol sulphate (SAL) and Ambroxol hydrochloride (AMB) in bulk and pharmaceutical dosage forms. A Phenomenex C18 column (250 x 4.6mm; 5 μm) with mobile phase containing 15mM ammonium acetate: acetonitrile (16:84% v/v) was used at isocratic mode and eluents were monitored at 227nm. The retention times of SAL and AMB were 3.1 min and 4.5 min respectively and showed a good linearity in the concentration range of 4- 20μg/mL for SAL and 30-150μg/mL for AMB with a correlation coefficient (R) of 0.999 and 0.999. The percentage assays were found to be 99.36 and 100.81 respectively for SAL and AMB. The proposed method was validated as per ICH guidelines and successfully applied for the simultaneous estimation of SAL and AMB in bulk and dosage forms.