波纳替尼及其杂质的染色学分析:方法开发,验证和新降解产品的识别
Jing Wang1, Yonghong Zhu2, Jisu Qin3
1Department of Pharmacy, Affiliated Hospital of Nantong University, Nantong, China.
Frontiers in chemistry
|November 27, 2024
概括
一种新的液态染色法有效检测白血病药物波纳替尼的杂质. 这种经过验证的方法通过识别相关物质和一种新型降解产品,imp-B.来确保药物安全和质量.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 药用化学 医学化学
背景情况:
- 波纳替尼是第三代氨酸激酶抑制剂,用于成人慢性髓性白血病.
- 波纳替尼的加工和降解杂质可能会影响其有效性和安全性.
- 准确检测这些杂质对于质量控制至关重要.
研究的目的:
- 开发和验证一种可靠的液态染色法 (LC) 方法来检测波纳替尼及其相关物质.
- 通过杂质分析,确保ponatinib的安全性和有效性.
主要方法:
- 使用Agilent 5HC-C18列进行分离.
- 采用了由水,乙二,二和三乙胺组成的移动相的梯度化方法.
- 优化的参数包括流速 (1.0mL/min),检测波长 (250nm),柱体温度 (40°C) 和注射体积 (10μL).
主要成果:
- 开发的LC方法表现出高的特异性,灵敏度,线性,精度,准确性和稳定性.
- 确定了一种新的氧化降解产物波纳替尼,命名为imp-B.
- 使用核磁共振 (NMR) 和高分辨率质谱 (HRMS) 阐明了imp-B的结构.
结论:
- 经过验证的LC方法适用于检测波纳替尼及其杂质.
- 这种方法为药物研究中波纳替尼的质量评估提供了宝贵的见解.
- 鉴定imp-B有助于更好地了解ponatinib降解途径.
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