开发和验证基于核心八基柱的稳定性指示高性能液态染色法,以确定散装Avermectin批量中Avermectin及其相关物质的Avermectin及其相关物质
Shane N Berger1, Abu M Rustum1
1Boehringer Ingelheim Animal Health USA Inc. (BIAH), 631 US Route 1 South, North Brunswick, NJ 08902, USA.
Journal of pharmaceutical and biomedical analysis
|February 27, 2025
概括
一种新的高性能液态染色法 (HPLC) 方法可靠地分析阿维尔麦丁和相关物质. 这种经过验证的方法为农业和动物卫生应用中的质量控制提供了关键数据.
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.
- 有机化学 有机化学
背景情况:
- 阿维尔麦克丁,来自Streptomyces avermitilis的宏环乳,是农业和动物卫生中的重要杀虫剂.
- 阿维尔麦克丁作为许多寄生虫杀虫剂的母化合物.
- 目前的药典专著 (Ph. 欧元,USP) 缺乏一种特定的HPLC方法来分析阿维尔麦克丁.
研究的目的:
- 开发和验证一个逆相HPLC方法,用于量化大批量Avermectin及其相关物质.
- 建立一个可靠的分析技术,用于阿维尔麦克丁的质量控制.
主要方法:
- 在45°C使用ACE UltraCore 2.5超级C18柱 (150mm × 4.6mm,2.5μm) 的梯度化.
- 移动阶段:5mM NH4OAc 在水 (pH 9.5) 和有机混合物 (乙基/甲醇/二甲,52/40.5/7.5v/v/v) 中.
- 检测和量化在245nm以0.05%的量化极限;根据ICH指南进行验证.
主要成果:
- 成功地分离了阿维尔麦丁和相关物质.
- 该方法证明了特异性,线性,精度,中间精度和稳定性,符合所有验证标准.
- 确定了0.05%的量化限制.
结论:
- 开发的逆相HPLC方法提供了对阿维美克丁及其相关物质的可靠分析.
- 这种方法解决了目前缺乏特定的药典HPLC专著的问题.
- 方法开发和强制降解数据为Avermectin家族提供了宝贵的见解.
更多相关视频
11:17Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
12.8K
08:56Detection of Regulated Ergot Alkaloids in Food Matrices by Liquid Chromatography-Trapped Ion Mobility Spectrometry-Time-of-Flight Mass Spectrometry
Published on: November 22, 2024
535
相关概念视频
01:13Principles Of Column Chromatography
6.6K
The chromatography technique was first invented in 1901 by Michael S. Tswett, a Russian botanist, to separate plant pigments using organic solvents. Further, in 1941, Archer John Porter Martin and R. L. M. Synge modified the technique by packing silica gel into a column. A mixture of amino acids was then separated on the packed column using chloroform and water mixture as the mobile phase. This was the first report on column chromatography. At present, column chromatography is a widely used...
6.6K
01:05High-Performance Liquid Chromatography: Elution Process
383
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...
383
01:11High-Performance Liquid Chromatography: Introduction
1.0K
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:
1.0K
00:57High-Performance Liquid Chromatography: Instrumentation
925
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.
925