染色谱光度测定使用逆相HPLC技术用于美沙拉或美沙拉胺
1Department of Pharmaceutical Chemistry, College of Pharmacy, University of Basrah, Iraq.
Georgian medical news
|November 22, 2023
概括
这项研究验证了一种新的HPLC-UV方法,用于在药品中量化美沙 (MESA). 开发的方法表现出高精度和准确性,适合分析仿制药产品.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 准确量化美沙 (MESA) 对于制药质量控制至关重要.
- 现有的方法可能需要对现代仿制药分析进行验证.
研究的目的:
- 开发和验证一个逆相HPLC (RP-HPLC) 方法,用于在药物配方中估计美沙 (MESA).
- 确认该方法用于分析仿制药产品的适用性.
主要方法:
- 使用逆相HPLC-UV方法与离子Pac柱 (Arcus EP-C18).使用逆相HPLC-UV方法.
- 采用亚二:酸:水 (40:40:20) 的移动相,与二二正酸缓冲剂 (pH 3.3) 一起使用.
- 检测是在260nm进行的,流量为1.0毫升/分钟.
主要成果:
- 该方法在1-5g/L范围内表现出极好的线性 (R2=0.9998).
- 量化极限为0.3613微克/毫升,检测极限为1.636微克/毫升.
- 恢复实验证实了高精度 (98.0%-100%) 和准确性.
结论:
- 经过验证的HPLC-UV方法是精确,准确和高效的梅萨拉量化.
- 与传统方法相比,拟议的方法没有显著差异.
- 这种分析技术适用于仿制梅萨拉药品的质量控制.
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