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双药分析的创新RP-HPLC策略:同时估计大量的selegiline和biochanin A以及SNEDDS

Shivani Tyagi¹, Manisha Trivedi², Jayendra Kumar¹

¹SRM Modinagar College of Pharmacy, Faculty of Medicine & Health Sciences, SRM Institute of Science and Technology, Delhi-NCR Campus, Delhi-Meerut Road, Modinagar, Ghaziabad, Uttar Pradesh- 201204, India.

Drug development and industrial pharmacy

|March 14, 2026

概括

一种新的RP-HPLC方法准确量化了大量的Selegiline (SEL) 和 Biochanin A (BCA) 和SNEDDS. 这种经过验证的方法支持开发用于帕金森病管理的新型药物输送系统.

科学领域:

分析化学分析化学
制药科学制药科学
药物输送系统药物输送系统

背景情况:

帕金森病 (PD) 管理需要有效的药物组合.
素 (SEL) 和生物素A (BCA) 显示出潜在的治疗协同作用.
准确的量化方法对于新药配方至关重要.

研究的目的:

开发和验证一个快速,准确和强大的RP-HPLC方法.
为了能够同时量化赛利吉林 (SEL) 和生物素A (BCA).
支持在散装和自纳米乳化药物输送系统 (SNEDDS) 中对SEL和BCA的分析.

主要方法:

使用Agilent 1220 Infinity II系统与5TC-C18(2) 列进行RP-HPLC分离.
异位移动相 (乙:水与o-酸,50:50v/v) 在1毫升/分钟.
方法根据ICH Q2 (R1) 准则进行验证;SNEDDS特性 (颗粒大小,PDI).

主要成果:

对于超过0.4-50μg mL-1.1的SEL和BCA,其线性非常好 (R2>0.9995).
系统适用性令人满意 (尾翼系数<1.5,分辨率>2,板材>2000).
证明了对变化的坚固性;SNEDDS具有120.3nm大小和0.1925 PDI.

结论:

一种简单,灵敏和强大的RP-HPLC方法被成功开发和验证.
该方法允许同时估计大量的SEL和BCA以及SNEDDS.
这种分析工具对于推进帕金森病的SEL-BCA组合疗法至关重要.

关键词:

分析方法验证的分析方法验证.生物素A 是一种生物素.在RP-HPLC中使用.在SNEDDS中,您可以使用SNEDDS.塞利吉林 (Selegiline) 是一种葡萄素.

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