通过与4-chloro-7-nitrobenzo-2-oxa-1,3-diazole衍生来确定二烯的三种技术
H Askar1, Mohammed E-S Metwally2, M M Tolba2
1Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Mansoura University, Mansoura, 35516, Egypt. hananymedhat89@yahoo.com.
BMC chemistry
|June 22, 2023
概括
开发了三种准确,快速和简单的分析方法,用于确定平板电脑配方中的平板电脑 (PRD). 这些环保方法,包括光谱光度测量,光谱度测量和HPLC,为PRD提供可靠的量化和内容统一性测试.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 绿色化学 绿色化学
背景情况:
- 在药品配方中精确确定二 (PRD) 对于质量控制至关重要.
- 现有的方法可能并不总是快速,简单或环保的.
- 开发新的分析技术对于满足现代制药标准至关重要.
研究的目的:
- 建立三种准确,快速和简单的方法来确定平板电脑形式的印布里尔.
- 将开发的方法与英国官方药典 (BP) 方法进行比较.
- 评估开发的方法是否适用于内容统一性测试,并评估它们对环境的影响.
主要方法:
- 谱光测定 (方法I) 基于PRD与4.0-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) 在pH9.0的反应,测量460nm的吸收度.
- 在 461 nm 激发后,在 535 nm 的 PRD-NBD-Cl 染色体的光谱测量测定 (方法 II).
- 高性能液体染色学 (HPLC) 与光检测 (方法III) 使用C18柱和甲醇-二酸盐 (60:40,v/v) 在pH3.0的移动相.
主要成果:
- 这三种方法都在指定度范围内显示出线性,具有良好的量化极限 (LOQ) 和检测极限 (LOD).
- 开发的方法已成功地用于估计片中的PRD,产生与官方BP方法 (定位) 相似的结果.
- 这些方法在内容统一性测试中被证明是有效的,并使用绿色分析程序指数 (GAPI) 验证为绿色和环保.
结论:
- 开发的光谱光度,光谱度和HPLC方法是准确的,简单的,快速的,适合于平板电脑中的常规测定.
- 这些分析方法对环境无害,符合绿色化学原则.
- 拟议的方法为药品质量控制和评估二配方的含量统一性提供了可靠的替代方案.
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