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8340971 
Journal Article 
A liquid chromatographic method for quantification of ropinirole hydrochloride and its related impurities 
Nagarjuna, A; Rao, SDV; Eswaraiah, S; Mukkanti, K; Suryanarayana, MV 
2006 
Indian Drug Manufacturers' Association 
43 
10 
813-820 
English 
A gradient reversed phase ion-pair liquid chromatographic method was developed for the quantitative determination of ropinirole hydrochloride related process impurities in bulk drugs. The. chromatographic separation was achieved on Hypersil BDS C8 (250 x 4.6 x 5 micron) column. The gradient liquid chromatographic method employs solution A and solution B as mobile phase. The solution A contains a mixture of 0.0.1 M phosphoric acid, 0.01 M sodium-1-Hexane sulphonate, pH-6.5:acetonitrile (85:15, v/v) and solution B contains a mixture of water:acetonitrile (40:60, v/v). The flow rate was 1.0 mL/min and the detection wavelength was 215 nm. The method is found to be precise, linear, accurate and also robust. The limit of detection and limit of quantification of impurities were ranged from 0.03 mcg/mL to 0.2 mcg/mL and 0.09 mcg/mL to 0.6 mcg/mL respectively for 10 mcL injection volumes. Ropinirole hydrochloride solutions were found to be stable for atleast 48 h. The method was also found to be stability indicating. 
HPLC; Ropinirole hydrochloride; Solution stability; Specificity; Validation