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

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• 作者：Ravi Kumar Konda^a ; ^d ; Babu Rao Chandu^b ; B.R. Challa^c ; ^{baluchalla_99@yahoo.com} ; Chandrasekhar B. Kothapalli^d
• 关键词：High performance liquid chromatography ; Mass spectrometry ; Rasagiline ; Liquid&ndash ; liquid extraction
• 刊名：Journal of Pharmaceutical Analysis
• 出版年：2012
• 出版时间：October, 2012
• 年：2012
• 卷：2
• 期：5
• 页码：342-349
• 全文大小：759 K

文摘

The most suitable bio-analytical method based on liquid-liquid extraction has been developed and validated for quantification of Rasagiline in human plasma. Rasagiline-¹³Cb>3b> mesylate was used as an internal standard for Rasagiline. Zorbax Eclipse Plus C18 (2.1 mm¡Á50 mm, 3.5 ¦Ìm) 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 total 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-¹³Cb>3b> 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.