开发一种经过验证的RP-HPLC方法,用于药物配方和人体血中的里瓦罗克萨班量化
Muhammad Jahangir1, Aymen Awan1, Arooj Azhar1
1Department of Chemistry, Government College University, Lahore, Pakistan.
Pakistan journal of pharmaceutical sciences
|October 23, 2023
概括
开发了一种新的,高效和经济的高性能液体染色学 (HPLC) 方法,用于确定药物和人体血中的抗凝剂里瓦洛克萨班. 这种经过验证的方法确保了对患者安全的准确量化.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 药理动力学 药理动力学
背景情况:
- 里瓦罗克萨班是一种重要的抗凝剂,用于预防关节或膝关节置换手术后的血栓.
- 药物配方和生物矩阵中Rivaroxaban的准确量化对于治疗疗效和患者安全至关重要.
研究的目的:
- 开发和验证一种简单,高效和具有成本效益的逆相高性能液态染色学与光电极阵列 (HPLC-PDA) 检测方法.
- 为了确定利瓦罗克萨班在药物剂型和人体血中的度.
主要方法:
- 使用了一种热科学ODSHypersil C18柱子,其移动相为70:30 乙酸/水,流量为1.2毫升/分钟.
- 在253nm使用PDA探测器进行检测,运行时间约为7分钟.
- 方法验证遵循国际协调理事会 (ICH) 的指导方针,在各种压力条件下评估线性,精度,准确性,稳定性和特异性.
主要成果:
- 开发的HPLC-PDA方法在100-400μg/mL范围内表现出极好的线性,相关系数为0.9996.6.
- 该方法被证明是精确的,准确的,坚固的,坚固的,在光解,热,氧化,酸性和基本应力条件下保持特异性.
- 在药物剂型和人体血样本中,Rivaroxaban的定量确定成功实现.
结论:
- 拟议的逆相HPLC-PDA方法是高效的,简单的,经济的,适合用于常规的Rivaroxaban的定量确定.
- 这种经过验证的分析方法可以可靠地用于药品中的里瓦罗克萨班的质量控制以及在人体血中对治疗药物的监测.
相关概念视频
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.