一种简单的环保稳定性指标HPLC方法,用于在散装和眼科溶液中确定NETILMICIN
Ahmed Sobhy Darwish1,2, Mohamed Samir Ahmed Zaki3, Ali GadKarim A Salih3
1Faculty of Science, Zagazig University, Zagazig, Egypt.
Biomedical chromatography : BMC
|June 23, 2025
概括
开发了一种新的环保方法,可以准确地测量散装和眼部溶液中的netilmicin. 这种绿色分析化学方法具有成本效益,并且符合国际协调理事会的验证标准.
科学领域:
- 分析化学 分析化学
- 绿色化学 绿色化学
- 药品分析 药品分析
背景情况:
- 网尔米辛是一种氨基糖化物抗生素,用于眼科溶液中.
- 准确可靠的方法对于药品质量控制至关重要.
- 开发环保的分析方法是制药科学中的一个越来越重要的优先事项.
研究的目的:
- 开发和验证一个环保的,稳定性指示的方法来确定netilmicin.
- 评估开发方法的环境影响和成本效益.
- 确保该方法符合国际协调理事会 (ICH) 的验证要求.
主要方法:
- 使用了高性能液态染色学 (HPLC).
- 使用了由乙醇和缓冲溶液 (pH3.5) 组成的移动相.
- 检测是在205nm进行的,分析运行时间在7分钟以下.
主要成果:
- 该方法表现出高度的环保性,以AES87和MoGAPI76.6等得分为证据.
- 该方法成功确定了在125.01000.0μg/mL的范围内净胺度.
- 根据ICH指南实现了验证,证实了方法的可靠性.
结论:
- 开发的方法是一种具有成本效益,环保和验证的稳定性指示测定对netilmicin.
- 这种绿色分析方法适用于散装和眼科医疗配方中netilmicin的常规质量控制.
- 这项研究强调了绿色化学原理在药物分析中的成功整合.
相关概念视频
High-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:
High-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...
High-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.
High-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...


