使用发明RP-HPLC技术,用于药品中 gabapentin 和甲基可巴胺的并行量化的绿色和白色分析方法
Samar M Mahgoub1, Fahad M Alminderej2, Ammena Y Binsaleh3
1Materials Science and Nanotechnology Department, Faculty of Postgraduate Studies for Advanced Sciences, Beni-Suef University, Beni-Suef, Egypt.
Scientific reports
|June 23, 2025
概括
一种绿色RP-HPLC方法在药品中同时量化 gabapentin (GAB) 和methylcobalamin (MET). 这种环保的方法可以确保可靠的质量控制,同时尽量减少对环境的影响.
科学领域:
- 分析化学 分析化学
- 绿色化学 绿色化学
背景情况:
- 药品质量控制需要精确量化药品活性成分.
- 开发环境可持续的分析方法对于减少制药生产的生态足迹至关重要.
研究的目的:
- 开发和验证一种简单,选择性和环境可持续的RP-HPLC方法,用于同时量化 gabapentin (GAB) 和methylcobalamin (MET).
- 通过使用已确定的环境指标来评估开发方法的绿色性.
主要方法:
- 在Zorbax Eclipse C8列上的RP-HPLC分离.
- 使用了绿色移动相:酸缓冲剂 (pH 6.9) /乙 (95:5 v/v).
- 在210纳米处检测,流量为2.0毫升/分钟.
主要成果:
- 极好的线性 (R2 > 0.9998) 和低的检测/定量化极限 (LODs: 0.60-0.80 μg/mL,LOQs: 2.00-2.50 μg/mL). 它们具有非常高的线性.
- 通过AGREE (0.70),AGREEprep (0.71) 和分析生态尺度 (80) 验证了环境可持续性.
- 方法通过强制降解研究证明了根据ICH指南的稳定性指示能力.
结论:
- 开发的RP-HPLC方法是一种可靠的,环保的工具,用于同时对药品的GAB和MET量化.
- 这种绿色分析方法在质量控制过程中显著降低了环境影响.
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:
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.
01:15High-Performance Liquid Chromatography: Types of Detectors
The role of the detectors in High-Performance Liquid Chromatography (HPLC) is to analyze the solutes as they exit from the chromatographic column. The detector recognizes the solute's property and generates corresponding electrical signals, which are converted into a readable graph of the detector's response versus elution time called a chromatogram at the computer. There are several types of HPLC detectors, each with its own advantages and limitations, depending on the analyte properties and...