溶解方法的适用性 关于评价digoxin产品质量的溶解方法
Rizwan Shaikh1, Swaroop J Pansare1, Bhanu P Dongala1
1Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX, USA.
AAPS PharmSciTech
|February 23, 2026
概括
一种新的UPLC方法准确量化了狄戈辛 (DGX) 和杂质. 迪戈辛片符合USP测定和溶解在水中的标准,但在酸中降解,稳定性问题影响溶解.
科学领域:
- 药品分析 药品分析
- 药品质量控制 药品质量控制
背景情况:
- 迪戈辛 (DGX) 是一种关键药物,需要严格的质量控制.
- 现有的分析方法可能无法充分评估DGX片的质量和稳定性.
研究的目的:
- 开发和验证用于DGX及其杂质的同时UPLC方法.
- 比较商业DGX平板电脑的溶解概况.
- 使用开发的方法评估DGX片的质量和稳定性.
主要方法:
- 根据ICH指南进行UPLC方法开发和验证.
- 质量评估包括检测和溶解测试.
- 在加速条件下的稳定性研究 (30°C/75%RH,40°C/75%RH).
- 在水和0.1 N HCl.中溶解测试.
- 用于结晶性分析的X射线粉末衍射.
主要成果:
- 对于DGX和关键杂质,UPLC方法显示了特异性,线性 (100-2000 ng/ml),准确性 (>98.6%) 和精度 (<3.3%).
- DGX片符合USP规格的测量 (>98%) 和溶解 (>85%在20分钟内溶解在水中).
- 降解发生在酸性介质中;光谱法缺乏特异性.
- 稳定性研究显示溶解减少了30%左右,结晶性增加,不符合USP规格.
结论:
- 开发的UPLC方法适用于评估DGX平板电脑质量.
- 在酸性介质中溶解测试和光谱测试对于常规QC是非特异性的和非歧视性的.
- 稳定性显著影响DGX片的溶解和物理性质.
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