Establishment of inherent stability of pramipexole and development of validated stability indicating LC-UV and LC-MS method  

作　　者：Shubhangi M.Pawar Laxman D.Khatal Satish Y.Gabhe Sunil R.Dhaneshwar 

机构地区：[1]Department of Pharmaceutical Chemistry,Poona College of Pharmacy,Bharati Vidyapeeth University,Pune,Maharashtra 411038,India [2]Bioanalytical Research Department,BioAnalytical Technologies Pvt.Ltd.,Pune,Maharashtra 411030,India [3]Department of Pharmaceutical Chemistry,RAK Medical and Health Sciences University,College of Pharmaceutical Sciences,Ras Al Khaimah 11172,United Arab Emirates

出　　处：《Journal of Pharmaceutical Analysis》2013年第2期109-117,共9页药物分析学报（英文版）

摘　　要：Pramipexole belongs to a class of nonergot dopamine agonist recently approved for the treatment of early and advanced Parkinson＇s disease.A validated specific stability indicating reversed-phase liquid chromatographic method has been developed for the quantitative determination of pramipexole in bulk as well as in pharmaceutical dosage forms in the presence of degradation products.Forced degradation studies were performed by exposition of drug to hydrolytic（acidic and basic）,oxidative and photolytic stress conditions,as defined under ICH guideline Q1A（R2）.Significant degradation was observed under hydrolytic,oxidative and photolytic conditions and the degradation products formed were identified by LC-MS.Pramipexole belongs to a class of nonergot dopamine agonist recently approved for the treatment of early and advanced Parkinson＇s disease.A validated specific stability indicating reversed-phase liquid chromatographic method has been developed for the quantitative determination of pramipexole in bulk as well as in pharmaceutical dosage forms in the presence of degradation products.Forced degradation studies were performed by exposition of drug to hydrolytic（acidic and basic）,oxidative and photolytic stress conditions,as defined under ICH guideline Q1A（R2）.Significant degradation was observed under hydrolytic,oxidative and photolytic conditions and the degradation products formed were identified by LC-MS.

关 键 词：Degradation products Forced degradation/stress studies Liquid chromatography mass spectrometry Pramipexole Reversed-phase liquid chromatography 

分 类 号：R927[医药卫生—药学]