Bio-analytical method development and validation of Rasagiline by high performance liquid chromatography tandem mass spectrometry detection and its application to pharmacokinetic study  

作　　者：Ravi Kumar Konda Babu Rao Chandu B.R.Challa Chandrasekhar B.Kothapalli 

机构地区：[1]Hindu College of Pharmacy,Amaravathi Road,Guntur,Andhra Pradesh 522002,India [2]Jawaharlal Nehru Technological University,Anantapur,Andhra Pradesh 515002,India [3]Don Bosco College of Pharmacy,Pulladigunta,Guntur,Andhra Pradesh 522001,India [4]Nirmala College of Pharmacy,Madras Road,Kadapa,Andhra Pradesh 516002,India

出　　处：《Journal of Pharmaceutical Analysis》2012年第5期342-349,共8页药物分析学报（英文版）

摘　　要：The most suitable bio-analytical method based on liquid liquid extraction has been developed and validated for quantification of Rasagiline in human plasma. Rasagiline-13C3 mesylate was used as an internal standard for Rasagiline. Zorbax Eclipse Plus C18 （2.1 mm × 50 mm, 3.5 um） column provided chromatographic separation of analyte followed by detection with mass spectrometry. The method involved simple isocratic chromatographic condition and mass spectrometric detection in the positive ionization mode using an API-4000 system. The lotal run time was 3.0 min. The proposed method has been validated with the linear range of 5 12000 pg/mL for Rasagiline. The intra-run and inter-run precision values were within 1.3% 2.9% and 1.6% 2.2% respectively for Rasagiline. The overall recovery for Rasagiline and Rasagiline-13C3 mesylate analog was 96.9% and 96.7% respectively. This validated method was successfully applied to the bioequivalence and pharmacokinetic study of human volunteers under fasting condition.The most suitable bio-analytical method based on liquid liquid extraction has been developed and validated for quantification of Rasagiline in human plasma. Rasagiline-13C3 mesylate was used as an internal standard for Rasagiline. Zorbax Eclipse Plus C18 （2.1 mm × 50 mm, 3.5 um） column provided chromatographic separation of analyte followed by detection with mass spectrometry. The method involved simple isocratic chromatographic condition and mass spectrometric detection in the positive ionization mode using an API-4000 system. The lotal run time was 3.0 min. The proposed method has been validated with the linear range of 5 12000 pg/mL for Rasagiline. The intra-run and inter-run precision values were within 1.3% 2.9% and 1.6% 2.2% respectively for Rasagiline. The overall recovery for Rasagiline and Rasagiline-13C3 mesylate analog was 96.9% and 96.7% respectively. This validated method was successfully applied to the bioequivalence and pharmacokinetic study of human volunteers under fasting condition.

关 键 词：High performance liquid chromatography Mass spectrometry RASAGILINE Liquid-liquid extraction 

分 类 号：R96[医药卫生—药理学]