Development and Validation of stability indicating RP-HPLC method for the simultaneous estimation of Beclomethasone dipropionate and Formoterol fumarate in their combined pharmaceutical dosage form.

Abstract

A simple, rapid, precise and accurate stability-indicating, RP-HPLC method was developed and validated for simultaneous estimation of BD and FF in bulk drug and its formulation. The method has shown adequate separation of BD and FF from their degradation products. Separation was achieved on a ODS Hypersil C18 (250mm× 4.6mmi.d, 5μm)column, kept at ambient temperature, using a mobile phase consisting of ammonium acetate buffer: Acetonitrile (30:70 v/v) at a flow rate of 1.5 ml/min and UV detection at 218nm. The average retention times for BD and FF were found to be 6.04min and 3.30 min respectively. BD and FF and their combination drug product were subjected to acid hydrolysis, alkali hydrolysis, oxidation, thermal and photolytic stress conditions. Validation of the method was carried out as per ICH guidelines. Linearity was established for BD and FF in the range of 30–70 and0.9–2.1μg/ml respectively. Correlation coefficient was found to be 0.9971 and 0.9984 for BD and FF respectively.