开发和验证微波辅助消化技术作为一种快速样品制备方法,用于估计 ICP-OESES 制药剂型中的
1Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, Gandhi Institute of Technology and Management (GITAM) (Deemed to be University), Visakhapatnam, Pin code: 530 045, Andhra Pradesh (State), India.
一种新的微波辅助消化技术可以准确量化硫化中的. 这种方法比现有的技术更快,更可复制,适合制药分析.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 是根据ICH Q3D指南的2B类元素.
- 硫化是一种抗感染剂,用于和斑疹性皮肤炎.
- 现有的估计分析方法往往耗时,需要高水平的技能.
研究的目的:
- 开发和验证一个节省时间的微波辅助消化技术,用于估计.
- 提供一种可复制和敏感的方法来分析硫化药物和配方中的.
主要方法:
- 优化了两步微波消化程序,使用二化,水和酸.
- 使用感应合等离子光学发射光谱学 (ICP-OES) 在196.090nm处量化.
- 验证了该方法的特异性,线性 (10-150 ppm),检测极限 (1.28 ppm),量化极限 (3.89 ppm),精度 (<2.0% RSD) 和准确性 (95%-105%).
主要成果:
- 开发的微波消化方法具有高度可重现性和节省时间.
- 分析验证证明了出色的特异性,线性,精度和准确性.
- 该方法在ICP-OES运行条件的轻微变化中被证明是可靠的.
结论:
- 一种经过验证的微波辅助消化技术可以有效量化硫化中的.
- 与传统技术相比,这种方法提供了更好的灵敏度,可重现性和速度.
- 开发的方法适用于含有硫化的各种制药矩阵.
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