在口服剂量配方和共形系统中新组合同时确定印米他辛和尼古丁胺的方法开发,使用三种紫外线光谱测光技术
Nazira Sarkis1, Abdulkader Sawan1
1Department of Analytical and Food Chemistry, Faculty of Pharmacy, University of Aleppo, Aleppo, Syria.
International journal of analytical chemistry
|February 28, 2024
概括
新的紫外线光谱法方法可以在各种制药配方中同时精确量化印米他辛 (IND) 和尼古丁胺胺 (NCT). 这些经过验证的技术为改善药物开发和质量控制提供了精确的分析.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 频谱光度测量是一种光谱光度测量.
背景情况:
- 印度甲 (IND) 和尼古丁胺 (NCT) 联合配方于2021年开发,以提高IND的溶解性,溶解性和稳定性.
- 结合IND和NCT可能会带来额外的治疗益处,需要可靠的量化方法.
- 准确同时确定IND和NCT对于质量控制和进一步研究至关重要.
研究的目的:
- 开发和验证简单,灵敏和精确的紫外光谱光度测量方法,用于同时定量IND和NCT.
- 在二元混合物,即时释放囊,持续释放囊和共形系统中分析IND和NCT.
- 评估开发的方法在各种药物剂量形式中的适用性.
主要方法:
- 采用了三种UV光谱技术:在二次导数中使用零交点,在一级导数中使用双波长,在比率减法中使用频谱减法.
- 方法验证是根据国际协调理事会 (ICH) 的指导方针进行的.
- 开发的方法用于分析不同制药配方中的IND和NCT.
主要成果:
- 开发的方法在2.5-40.0μg/mL范围内显示出良好的线性.
- 在所有方法中,IND和NCT都实现了低检测极限 (LOD) 和量化极限 (LOQ).
- 提出的方法成功地应用于药物配方,与参考方法相比没有显著的统计差异.
结论:
- 开发的紫外线光谱仪技术提供了可靠和有效的手段,可以同时确定印米他辛和尼古丁胺胺.
- 这些经过验证的方法适用于各种剂型的IND/NCT的常规质量控制分析.
- 该研究证实了拟议的分析技术在制药分析中的稳定性和适用性.
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