在实验室中通过经过验证的,稳定性指示的HPLC方法,对约旦的西德纳菲尔仿制药的溶解等效
Hamdi Nsairat1, Ali Al-Samydai1, Mohamed El-Tanani1,2
1Pharmacological and Diagnostic Research Center, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, 19328, Jordan.
Bioanalysis
|March 18, 2024
概括
这项研究使用HPLC分析将约旦的西尔代纳菲尔 (SDF) 产品与原始产品进行了比较. 所有本地SDF产品都符合溶解标准,证明了有效的体外药物释放.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
背景情况:
- 西尔德纳菲尔 (SDF) 是一种广泛使用的药物.
- 确保仿制药的质量和生物等价性对于患者安全和治疗疗效至关重要.
- 溶解概况是药物性能的关键指标.
研究的目的:
- 为了比较四个注册的约旦西尔代纳菲尔产品与原始产品的体外溶解概况.
- 验证一种稳定性指示HPLC方法,用于在人体血和溶解介质中定量化西尔代纳菲尔.
主要方法:
- 采用了经过验证的,稳定性表明的高性能液态染色学 (HPLC) 方法.
- 西尔德纳菲尔从血中提取,使用液体-液体提取.
- 溶解测试在各种介质中对西尔德纳菲尔产品进行,样本通过HPLC进行分析.
主要成果:
- 该HPLC方法显示出优异的线性 (R2∼0.999),良好的药物恢复 (86.689.8%),以及较低的量化极限 (10 ng/ml).
- 分析方法显示,在各种条件下,西尔代纳菲尔的选择性和稳定性很高.
- 所有经过测试的约旦西尔德纳菲尔产品都表现出不同介质的相似性因子,但成功通过了体外溶解试验,在60分钟内释放了超过85%的药物.
结论:
- 经过验证的HPLC方法适用于在生物矩阵和溶解介质中量化西尔代纳菲尔.
- 所有评估的约旦西尔代纳菲尔产品都符合所需的体外溶解规格,这表明药物释放性能与原始产品相比较.
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