Stability indicating RP-HPLC assay method for pramipexole dihydrochloride in pure and formulations

Abstract

A simple, rapid, accurate and precise RP-HPLC method is developed for the determination of pramipexole dihydrochloride in pure and dosage forms. Separation of the pramipexole dihydrochloride was achieved on a reverse phase Hypersil BDS C18 Column (250 mm x 4.6 mm, 5μm) using the mobile phase [phosphate buffer [pH-3.0]: Acetonitrile in the ratio of 40:60, v/v] with a flow rate of 1.0mL/min and detection at 264 nm. The method showed a linear response in the range of 10-30 μg/mL and retention time was 6.791 min. The method was statistically validated for linearity, accuracy, precision and selectivity as per ICH guidelines. The drug was subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis and thermal degradation to show the stability-indicating power of the developed RP-HPLC method. The present method can be successfully used for routine quality control analysis of pramipexole dihydrochloride and stability studies.