东道主-客人兴奋剂室-温度光传感策略用于检测纳普罗APL中的相关物质,以及生产剂型的剂量形式
Xiwen Zhu1, Shishi Shao1, Jialu Zheng1
1Key Laboratory of Biomedical Analytics, Chongqing Science and Technology Bureau, College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, P. R. China.
Analytical chemistry
|February 9, 2026
概括
一种新的室温光 (RTP) 传感策略快速检测纳普罗森活性药物成分 (API) 和剂型中的微量杂质. 这种主机-客户兴奋剂方法为传统的杂质检测提供了一个敏感的,符合药典的替代方案.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 在活性药物成分 (API) 和药物产品中检测杂质对于质量和安全至关重要.
- 结构相似的杂质会导致光谱重叠,挑战HPLC等传统分析方法.
- 过程分析技术 (PAT) 提供实时监控,但需要敏感的检测策略.
研究的目的:
- 开发一种快速而灵敏的方法,用于检测纳普罗API和剂量形式中的微量杂质.
- 为制药杂质分析引入一种新的宿主-客服兴奋剂室温光 (RTP) 传感策略.
- 为了证明在过程分析技术 (PAT) 框架内RTP传感的适用性.
主要方法:
- 开发了一种利用室温光 (RTP) 的宿主-客人兴奋剂策略.
- 该方法利用在最小主体含量下低发光效率进行敏感杂质检测.
- 开发的RTP方法与高性能液态染色学 (HPLC) 进行了验证,以量化杂质.
主要成果:
- 在RTP感知策略中,成功检测到纳普洛克森API中的微量2-乙-6-甲氨 (MANAP) 杂质.
- 达到0.05% (w/w) 的检测极限 (LOD),超过了0.1% (w/w) 的药库值.
- 该方法在统计上与HPLC相等,平均恢复率在98.03%至103.38%之间.
结论:
- 开发的宿主-客人兴奋剂RTP传感策略为制药杂质测试提供了快速和灵敏的方法.
- 这种基于RTP的新PAT方法适用于纳普洛森制造中的实时杂质监测.
- 该战略提供了一个有前途的替代方案,通过有效的杂质检测来确保药品质量和临床安全.
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