应用TGA/c-DTA用于区分两种形式的纳普罗在药品制剂中的应用
Paweł Ramos1, Barbara Klaudia Raczak2, Daniele Silvestri3
1Department of Biophysics, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Jedności 8, 41-200 Sosnowiec, Poland.
Pharmaceutics
|June 28, 2023
概括
热分析方法,如热重力测量 (TGA) 和差分热分析 (c-DTA),可以快速且负担得起地区分药物中的纳酸和纳酸. 这些方法为复杂的药典技术提供了一个有希望的替代方案.
科学领域:
- 药品分析 药品分析
- 分析化学 分析化学
- 材料科学 材料科学 材料科学
背景情况:
- 纳普罗是一种广泛使用的非类固醇抗炎药物 (NSAID),存在于制药制剂中的酸和盐.
- 区分这些形式对于制药分析至关重要,但目前的方法往往是昂贵和耗时的.
研究的目的:
- 研究热分析技术的有效性,特别是热重力测量 (TGA) 和计算差异热分析 (c-DTA),用于识别纳普罗形式.
- 评估这些热方法作为现有的药典识别程序的更快,更便宜,更简单的替代方案.
主要方法:
- 热重力测量 (TGA) 和计算差异热分析 (c-DTA) 用于分析商业制药制剂中的纳素.
- 热方法与已建立的药典技术进行了比较,包括HPLC,FTIR,UV-Vis光谱光度和色度分析.
- 使用纳布梅评估了特异性,纳布梅是纳普罗的结构模拟物.
主要成果:
- 通过c-DTA支持的TGA在区分纳普罗森酸和纳普罗森之间证明了有效性和选择性.
- 热分析方法被证明是一个可行的替代传统的,更繁重的识别技术.
结论:
- 热分析,特别是TGA与c-DTA相结合,为识别药品中纳普罗形式提供了有希望,高效和成本效益的方法.
- 这些方法在常规药物分析中具有作为一种有价值的替代品的潜力.
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