用于优化多模HPLC方法的分析QbD,用于研究从3D打印配方中释放的甲,迪尔提亚泽姆和兰醇的3D打印配方
Irene Maria Samara1, Marianna Ntorkou1, Christos I Gioumouxouzis2
1Laboratory of Pharmaceutical Analysis, Department of Pharmacy, Aristotle University of Thessaloniki, GR-54124, Greece.
Journal of pharmaceutical and biomedical analysis
|June 26, 2024
概括
一种新的混合模式液态染色法方法可以在8分钟内有效地分离甲酸,迪尔提亚泽姆和醇. 这种经过验证的方法分析3D打印平板电脑中的药物释放.
科学领域:
- 制药技术 制药技术 制药技术
- 分析化学 分析化学
- 染色体学 染色体学 是一种染色学.
背景情况:
- 3D打印是制药配方中的新兴技术.
- 从新型剂型中分析药物释放需要强大的分析方法.
研究的目的:
- 开发和验证一种混合模式液态染色法 (HPLC) 方法,用于分离和定量化,化和醇.
- 调查这些API从3D打印平板电脑中的体外药物释放性能.
主要方法:
- 方法开发遵循了设计时分析质量 (AQbD) 的原则,包括风险评估和多变量分析.
- 混合模式静止阶段在同位素化下使快速分离 (<8分钟) 成为可能.
- 验证使用总错误概念进行,评估偏差和精度.
主要成果:
- 开发的HPLC方法表现出高准确度和精度,相对偏差在-11.6%和10.5%之间,RSD<4.4%.
- 检测极限 (0.17-0.90μg/mL) 适用于分析体外释放样本.
- 该方法成功分析了含有三个活性药物成分的3D打印片中的药物释放.
结论:
- 成功开发了一种强大且经过验证的混合模式HPLC方法,用于分析化,diltiazem和propranolol.
- 该方法适用于从3D打印制药配方中研究这些药物的体外药物释放特性.
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