开发和验证一种稳定性指示的UPLC-DAD方法,用于药物片和溶解介质中同时确定伊弗梅克和普拉齐

相关实验视频

Updated: Jul 13, 2025

Optimized Griess Reaction for UV-Vis and Naked-eye Determination of Anti-malarial Primaquine

Optimized Griess Reaction for UV-Vis and Naked-eye Determination of Anti-malarial Primaquine

Published on: October 11, 2019

Ahmed Ibrahim¹, Fang Wang¹, R Gary Hollenbeck¹

¹School of Pharmacy, University Maryland Baltimore, 20 N. Pine St., Baltimore, Maryland, 21201, USA.

AAPS PharmSciTech

|October 11, 2023

概括

一种新的超高性能液态染色法 (UPLC) 方法可以同时准确量化艾弗麦克和普拉齐. 这种稳定性指示方法对于制药分析和质量控制至关重要.

科学领域:

分析化学分析化学
药品分析药品分析

背景情况:

由于缺乏单一,快速和准确的稳定性指示方法,对ivermectin和praziquantel的同时量化具有挑战性.
现有的方法可能不能充分解决相关化合物和降解产品的确定.

研究的目的:

开发和验证一种新,快速,准确和稳定性指示的超高性能液态染色学 (UPLC) 方法,用于同时测定艾弗梅克和普拉齐.
确保该方法能够有效地将活性药物成分 (API) 与杂质和降解产品分离和量化.

主要方法:

超高性能液态色谱 (UPLC) 使用C18列,其中含有水,酸和甲醇的梯度化.
在245纳米处检测,柱体温度保持在40°C,流量为0.7毫升/分钟.
根据国际协调理事会 (ICH) Q2R1指南进行验证,包括线性,准确性,精度,特异性,LOD/LOQ和稳定性.

主要成果:

优异的线性,R2值>0.9987对于普拉齐特尔和>0.9997对于ivermectin.
高精度 (98.0-102.0%) 和中等精度 (两种分析物<2.0%CV).
经过证明的特异性,稳定性指示能力,以及对方法参数中微小变化的稳定性.

结论:

开发的UPLC方法具有特异性,准确性,灵敏性和稳定性,可用于同时量化ivermectin和praziquantel.
这种经过验证的方法为制药质量控制和稳定性研究提供了可靠的工具.
该方法的稳定性确保在典型的实验室条件下保持一致的性能.

关键词:

在UPLC和HPLC的方法验证中.分析溶解方法分析溶解方法测试方法开发测试方法的开发.艾弗梅克丁和普拉齐昆尔片类药物制品药物产品稳定性指示反相超强性液体染色学 (RP-UPLC) 方法

更多相关视频

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

Published on: August 30, 2018

Formation of Dispersible Taohong Siwu Tablets

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

相关概念视频

Protein-Drug Binding: Determination Methods

Protein-Drug Binding: Determination Methods

Determining protein-drug binding can be achieved through indirect and direct methods, each providing valuable insights into the interaction between proteins and drugs.
Indirect methods involve isolating the bound drug from its free form in biological samples such as blood, serum, or plasma. These techniques aim to measure the percentage of drugs bound to proteins. Equilibrium dialysis is a commonly used method where the free drug concentration at equilibrium is measured by separating the bound...

Factors Influencing Drug Absorption: Pharmaceutical Parameters

Factors Influencing Drug Absorption: Pharmaceutical Parameters

Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...