液体染色学-双重质谱法用于定量人体血中埃尔格利弗洛辛的量化:应用到处置动力学上的应用
Viritha Bezawada1, Padma Mogili1, Sireesha Dodda2
1Department of Engineering Chemistry, College of Engineering, Andhra University, Visakhapatnam, AP, India.
概括
一种新的高性能液态色谱-并联质谱法准确地量化了人体血中的 ertugliflozin. 这种经过验证的方法已成功应用于药理动力学研究,确定了关键的吸收参数.
科学领域:
- 分析化学 分析化学
- 药理动力学 药理动力学
- 质谱测量质量谱测量
背景情况:
- 埃尔图格利弗洛辛是一种用于治疗2型糖尿病的SGLT2抑制剂.
- 在生物矩阵中精确量化埃尔特格利弗洛辛对于药理动力学研究至关重要.
- 现有的分析方法可能需要对灵敏度和效率进行优化.
研究的目的:
- 开发和验证一种灵敏,强大的高性能液体染色学-并联质谱法 (HPLC-MS/MS) 方法,用于在人体血中量化埃尔格利弗洛辛.
- 应用经过验证的方法,在健康志愿者口服后评估euregliflozin的药理动力学.
主要方法:
- 使用HPLC-MS/MS对艾尔格里夫洛辛的量化,以艾尔格里夫洛辛D5作为内部标准.
- 样品的制备涉及甲基三级乙基液体-液体提取.
- 在Kromasil-C18柱上进行了染色分离,其中使用的是甲醇/氨酸形式的移动相.
- 检测采用了正离子电喷射电离化模式的多重反应监测 (MRM).
主要成果:
- 该方法在1-500 ng/mL (r2 > 0.99) 的度范围内显示出出色的线性.
- 根据美国FDA指南的方法验证证实了在可接受范围内得到的结果.
- 该试验成功地应用于15毫克口服艾特格利弗洛辛的药理学研究,产生Cmax为288.28 ng/mL和Tmax为1.32小时.
结论:
- 一种经过验证的HPLC-MS/MS方法可以准确可靠地量化人体血中的euregliflozin.
- 开发的方法是适合支持farmacokinetic和生物等价性研究的 ertugliflozin.
- 在健康志愿者中获得的药理动力学参数为eurgliflozin的吸收概况提供了宝贵的见解.
关键词:
埃尔图格利弗洛辛 (Eurtugliflozin) 是一种一种药物.生物分析是一种生物分析.发生的样本重新分析.液态色谱-双重质谱法/质谱法 质谱法液体液体提取方法 液体液体提取方法药物动力学研究 药物动力学研究更多相关视频
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