稳定性指示RP-HPLC方法开发和验证用于确定洛佩拉米德化囊剂量形式中的杂质.
Sreenivas Pippalla1, Vaishnavi Chintala2
1Sikkim Professional University Gangtok, Gangtok, Sikkim, India.
Biomedical chromatography : BMC
|March 12, 2025
概括
一种新的基于质量设计 (QbD) 的高性能液态染色学 (HPLC) 方法准确量化了洛佩拉胺 (LPH) 片中的杂质和降解剂. 这种经过验证的稳定性指示方法确保了产品质量,并支持常规制造分析.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 洛佩拉胺 (LPH) 需要强大的分析方法来进行质量控制.
- 识别和量化杂质和降解剂对于制药产品的安全性和有效性至关重要.
研究的目的:
- 开发和验证基于设计 (QbD) 的高性能液态染色学 (HPLC) 稳定性指示方法,用于洛佩拉米德化 (LPH) 片中的杂质.
- 为常规质量分析和稳定性研究建立可靠的方法.
主要方法:
- 采用QbD方法开发了一个高分辨率的HPLC方法.
- 该方法使用特定的梯度化与生肖C18列.
- 强制降解研究 (酸性,氧化性,热性) 进行,以评估方法的稳定性指示性质.
主要成果:
- 开发的HPLC方法为八种已知的杂质实现了出色的峰值分辨率,并量化了三种降解剂.
- 压力研究表明,LPH对各种降解条件的敏感性.
- 该方法被证明是稳固的,纯度角度始终低于强制降解下的值.
结论:
- 经过验证的HPLC方法适用于准确确定LPH片剂剂型中的杂质和降解剂.
- 这种基于QbD的方法支持药品制造业的常规质量控制和稳定性测试.
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