环保色谱技术用于质量控制的葡萄糖胺,红素和酸在两个散装和囊配方
Jin-Kui Ma1, Xiao-Yang Chen1, Yu-Tong Lin1
1School of Food & Pharmaceutical Engineering, Zhaoqing University, Zhaoqing, China.
Biomedical chromatography : BMC
|March 12, 2026
概括
这项研究开发了一种负担得起的,环保的高性能液体染色学 (HPLC) 方法,用于同时检测红素,葡萄糖胺和酸. 经过验证的技术可确保药品和食品的质量控制.
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:
- 准确量化度素,葡萄糖胺和甲酸对于制药和食品质量控制至关重要.
- 现有的分析方法可能缺乏生态意识或负担能力.
- 开发稳定性指示方法对于评估药物产品完整性至关重要.
研究的目的:
- 设计和验证一种新的,负担得起的和环保的白色高性能液体染色学 (HPLC) 稳定性指示技术.
- 为了能够同时检测ondroitin,葡萄糖胺和甲酸.
- 应用分析散装材料和制药/食品囊的方法.
主要方法:
- 使用特定的移动相组合 (二酸,1-赫酸硫酸,酸单基缓冲剂,乙,甲醇) 在0.6毫升/分钟的流速下.
- 使用 190 nm 的检测波长,注入量为 10 μL.
- 验证了该方法的线性,准确性和精度在每个分析物的指定度范围内.
主要成果:
- 在运行时间<6.5分钟内,同时检测到了ondroitin (175.13502 ppm),葡萄糖胺 (375.67512 ppm) 和酸 (30.2603.2 ppm).
- 通过高白度得分和各种绿色化学指标 (例如,AES 84,AGSA 69.44,CaFRI 85) 证明了显著的生态效益.
- 已确认方法与国际协调委员会 (ICH),欧洲药品署 (EMA) 和美国食品和药物管理局 (FDA) 的验证要求保持一致.
结论:
- 开发的白色HPLC方法是一种经过验证,具有成本效益和环境可持续的分析工具.
- 它可靠地量化了各种矩阵中的ondroitin,glucosamine和ascorbic acid.
- 该方法支持监管合规,并在制药和食品行业促进更绿色的分析实践.
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