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首页> 美国卫生研究院文献>Journal of Pharmaceutical Analysis >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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Bio-analytical method development and validation of Rasagiline by high performance liquid chromatography tandem mass spectrometry detection and its application to pharmacokinetic study

机译：高效液相色谱串联质谱检测雷沙吉兰生物分析方法的开发与验证及其在药代动力学研究中的应用

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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 μm) 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-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.
机译：已经开发了最合适的基于液-液萃取的生物分析方法，并已用于定量人体血浆中的雷沙吉兰。雷沙吉兰- 13 C3甲磺酸盐被用作雷沙吉兰的内标。 Zorbax Eclipse Plus C18（2.1mm×50mm，3.5μm）色谱柱提供分析物的色谱分离，然后进行质谱检测。该方法涉及简单的等度色谱条件和使用API​​-4000系统在正电离模式下的质谱检测。总运行时间为3.0分钟。雷沙吉兰的线性范围为5–12000 pg / mL，已验证了所提出的方法。雷沙吉兰的批内和批间精密度值分别在1.3％–2.9％和1.6％–2.2％之内。雷沙吉兰和雷沙吉兰- 13 C3甲磺酸酯类似物的总回收率分别为96.9％和96.7％。该验证方法已成功应用于禁食条件下人类志愿者的生物等效性和药代动力学研究。

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