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在人体血中用于cinacalcet的生物分析双重质谱法:使用高级指标进行绿色评估

Anil Kollapareddy¹, Kousrali Sayyad¹, Leela Prasad Kowtharapu²

¹Department of Chemistry, Koneru Lakshmaiah Education Foundation, Hyderabad, India.

|July 29, 2025

概括

一种新的LC-MS/MS方法准确地量化了血中的cinacalcet,有助于治疗二次性甲状腺功能障碍和高血症. 这支持治疗药物监测和药理动力学研究,以改善患者的治疗结果.

科学领域:

分析化学分析化学
药理学药理学是指药理学的学科.

背景情况:

慢性病 (CKD) 患者的二次性偏甲状腺症 (SHPT) 和特定内分泌条件下的高血症需要有效的管理.
在这些患者群体中,甲状腺激素 (PTH) 的降低中,甲,一种仿药,至关重要.

研究的目的:

开发和验证一种高性能液体染色体协同质谱法 (LC-MS/MS) 方法,用于量化cinacalcet.
为了支持治疗药物监测和cinacalcet的药理学研究.

主要方法:

使用cinacalcet-D3作为内部标准,开发了一种敏感的LC-MS/MS测定.
量化在正离子模式的三重四重质谱仪上使用C18柱进行了量化.

主要成果:

经过验证的方法显示了高精度,准确性和线性 (0.300-150.00 ng/mL).
该试验被证明是稳定的,适合用于人类血分析.
绿色化学指标被用来评估环境可持续性.

结论:

在人体血中成功开发了一种针对人体血中cinacalcet的强大和选择性的LC-MS/MS试验.
该试验非常适合用于药理动力学研究,治疗药物监测和生物等价性评估.

关键词:

生物等价性生物等价性根据ICH M10指导方针在中国,酸 (Cinacalcetcet) 是一种高性能液体色谱与双重质谱的高性能液体色谱.液体液体提取方法液体液体提取方法

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