一种简单的HPLC-UV方法用于在人体血中确定伊沃西代尼布
1Department of Medicinal Therapy Research, Pharmaceutical Education and Research Center, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo 204-8588, Japan.
Journal of chromatographic science
|October 24, 2023
概括
一种新的HPLC-UV方法准确地量化了血中的IVOSIDENIB,有助于对急性髓性白血病 (AML) 患者的治疗药物监测,并可能降低毒性风险.
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.
- 临床化学 临床化学
背景情况:
- 伊沃西登尼布治疗具有IDH1突变的急性髓性白血病 (AML).
- 较高的IVOSIDENIB水平与QT间隔延长相关,这可能是心脏风险.
- 治疗药物监测 (TDM) 可以优化ivosidenib治疗的有效性和安全性.
研究的目的:
- 开发和验证一种高性能液体色谱-紫外线 (HPLC-UV) 方法,用于量化人体血中的ivosidenib.
- 提供一种可靠和可访问的方法,用于ivosidenib的TDM.
主要方法:
- 血样本经过蛋白质沉与酸.
- 染色分离使用了反向相柱和同位素移动相.
- 紫外线检测是在245nm进行的.
主要成果:
- 在0.25-20μg/mL (r2 = 0.99999) 的度范围内,HPLC-UV方法证明了线性.
- 测试精度和准确性处于可接受的范围内 (一天内/一天内精度:1.20-8.04%/0.69-4.20%;精度:-2.00%至1.93%).
- 高回收率 (>91.2%) 证实了方法的有效性.
结论:
- 开发的HPLC-UV方法是有效的,适合在人体血中量化ivosidenib.
- 这种简单,具有成本效益的测定可以促进更广泛的ivosidenib监测,特别是在没有LC-MS/MS的实验室.
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