开发和验证HPLC-紫外线方法,用于在人类胎盘 perfusion 介质中定量确定pritelivir
Xiaoming Wang1, Svetlana Patrikeeva1, Tatiana Nanovskaya1
1Maternal-Fetal Pharmacology and Bio-Development Laboratories, Department of Obstetrics & Gynecology, University of Texas Medical Branch, Galveston, Texas, USA.
Biomedical chromatography : BMC
|May 10, 2024
概括
一种新的HPLC-UV方法准确地量化了胎盘 perfusion 样本中的pritelivir. 这种可靠的方法可确保精确的药物度测量用于ex vivo胎盘研究.
科学领域:
- 药理动力学和药物新陈代谢
- 分析化学 分析化学
- 生殖毒理学 生殖毒理学
背景情况:
- 人的胎盘在母亲和胎儿之间的药物传输中起着至关重要的作用.
- 在胎盘组织中精确量化像普里特利维尔这样的抗病毒药物对于安全性和有效性研究至关重要.
- 活体胎盘输液模型是评估药物处置的宝贵工具.
研究的目的:
- 开发和验证一种简单,可靠的高性能液体染色学-紫外线 (HPLC-UV) 方法.
- 量化人类胎盘 perfusion 介质中的pritelivir度.
- 为了确保pritelivir测量的准确性和精确性,用于药理动力学评估.
主要方法:
- 开发一种使用C18柱和甲醇-水移动相的HPLC-UV方法.
- 普里特利维尔与纳作为254nm的内部标准的量化.
- 用蛋白沉提取方法验证该方法的线性,准确性,精度和回收.
主要成果:
- 该方法在0.1556.62μg/mL范围内显示出出色的线性 (r2 > 0.99).
- 在一天内和一天之间准确度在97%至110% (RSD ≤10%) 之间.
- 对于普利特利维尔和内部标准的提取恢复率很高 (8991%,RSD ≤7%),并证实了普利特利维尔的稳定性.
结论:
- 一种经过验证的HPLC-UV方法提供了一种可靠的方法,用于在胎盘 perfusion 研究中量化pritelivir.
- 该方法通过在相关的ex vivo模型中准确测量药物度来支持药物动力学研究.
- 经过验证的试验确保了用于药物安全性和有效性评估的普里特利维尔度数据的完整性.
相关概念视频
01:11High-Performance Liquid Chromatography: Introduction
High-performance liquid chromatography(HPLC), formerly referred to as High-pressure liquid chromatography, is a powerful technique used to separate, identify, and quantify components in complex mixtures. The term "high pressure" refers to using high pressure to push the liquid mobile phase through the tightly packed columns.
In HPLC, two phases play a critical role in the separation process:
In HPLC, two phases play a critical role in the separation process:
01:05High-Performance Liquid Chromatography: Elution Process
In High-Performance Liquid Chromatography (HPLC), the elution process is critical to the separation of analytes and the quality of chromatographic results. Elution describes how compounds move through the column and separate based on their interactions with the mobile and stationary phases. This process determines the resolution, peak shape, and retention times in the chromatogram, which are essential for identifying and quantifying components in complex mixtures. Understanding the elution...
00:57High-Performance Liquid Chromatography: Instrumentation
High-performance liquid chromatography, or HPLC, is an analytical technique that separates liquid samples under high pressures. An HPLC instrument consists of glass bottles for storing solvents called mobile phase reservoirs. HPLC-grade solvents are used to maintain high purity, and the dissolved gases are removed using a degasser, such as a vacuum pumping system or sparging with helium. The solvents are then pumped into the analytical column using a screw-driven syringe or reciprocating pumps.