瓦尔贝纳异构体和异构体的确定通过奇拉正常相液色谱
Balasaheb R Deshmukh1, Parameswari Akshinthala2, Naresh Kumar Katari3
1Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Visakhapatnam, Andhra Pradesh, India.
一种新的性高性能液态染色法方法有效地分离了瓦尔贝纳异构体和反构体. 这种经过验证的技术确保了药品质量控制的准确量化.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 瓦尔贝纳是一种制药剂,需要精确的异构和反构量化.
- 现有的分析方法可能缺乏用于全面分析瓦尔贝纳的特异性或效率.
研究的目的:
- 为Valbenazine开发和验证一种新的,对Valbenazine进行enantioselective正常相奇拉HPLC方法.
- 为了确保准确地分离和量化瓦尔贝纳异构体和反构体.
主要方法:
- 使用基于粉的Chiral Pak IG-3柱 (250 × 4.6毫米,3.0微米).
- 采用了n-heptane,异醇,二甲,乙醇和乙胺的梯度移动相 (70:10:15:5:0.1 V/V/V/VV).
- 在282nM的探测使用光二极管阵列探测器,柱体温度为35°C.
主要成果:
- 在异构体和异构体之间实现分辨率>2.0.
- 在从量化限值到250%的度范围内证明了线性.
- 该方法被证明是可靠的,特别是对于柱体温度变化.
结论:
- 开发的性HPLC方法是简单的,特定的,快速的,和enantioselective.
- 该方法适用于在批量制造药物和制药质量控制中确定瓦尔贝纳异构体和异构体.
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