Development and validation of a stability-indicating method for determination of ropinirole in the bulk drug and in pharmaceutical dosage forms

Abstract

An accurate, sensitive, precise, rapid, and isocratic reversed phase HPLC (RP-HPLC) method for analysis of ropinirole in the bulk drug and in pharmaceutical preparations has been developed and validated. The best separation was achieved on a 250 mm × 4.6 mm i.d, 5-μm particle, C 18 reversed-phase column with methanol-0.05 m ammonium acetate buffer (pH 7) 80:20 (v/v) as mobile phase, at a flow rate of 1 mL min-1. UV detection was performed at 250 nm. The method was linear over the concentration range 0.2-100 μg mL-1 (r = 0.9998), with limits of detection and quantitation of 0.061 and 0.184 μg mL-1, respectively. The drug was subjected to oxidation, hydrolysis, photolysis, and heat as stress conditions. Degradation products resulting from the stress did not interfere with detection and assay of ropinirole and thus the method can be regarded as stability-indicating. The method can be used for quality-control assay of ropinirole. © 2008 Akadémiai Kiadó.