在Leucovorin药物产品中有效且同时检测N-Nitroso和Di-NitrosoLeucovorin的LC-MS/MS:方法开发和验证
Jaya Yalamanchili1, Himavathi Ganja1, Suresh Salakolusu1,2
1Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Vishakhapatnam, Andhra Pradesh, India.
Rapid communications in mass spectrometry : RCM
|March 11, 2026
概括
一种新的分析方法有效地测量了药品中的N-nitroso leucovorin和di-nitroso leucovorin杂质. 这一进步有助于制药商控制这些潜在有害化合物,提高患者安全和监管合规性.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 不洁净性分析 (Impurity Profiling) 是一种分析方法.
背景情况:
- 与N-nitroso药物物质相关的杂质 (NDSRI) 由于其致癌潜力,在药品中引起了重大关注.
- 现有的染色学方法难以将结构相似的NDSRI与活性药物成分分开.
- 开发特定的分析方法对于量化药物产品中的NDSRI至关重要.
研究的目的:
- 开发和验证一种用于量化Leucovorin药物中的N-nitrosoleucovorin和di-nitrosoleucovorin的新型分析方法.
- 为了应对从活性药物成分中分离结构相似的杂质的挑战.
主要方法:
- 量化使用选择性反应监测和正电子喷雾电离源进行量化.
- 通过使用甲醇和水 (0.1%的酸) 的梯度化逆相C-8柱实现了分离.
主要成果:
- 该方法证明了从0.1到1.5ng/mL的线性 (10%150%的监管极限).
- 检测和定量极限分别为0.05 ng/mL和0.1 ng/mL.
- 该方法对目标杂质具有出色的特异性,精度,线性,准确性和稳定性.
结论:
- 这种经过验证的方法为制药商提供了一个至关重要的工具,以监测和控制N-nitroso leucovorin和di-nitroso leucovorin水平.
- 这种方法的实施将改善监管合规性,并确保更大的患者安全.
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