快速,简单和低成本的分析方法开发,用UV光谱法量化Eltrombopag Olamine在片剂中的剂量
Nandan Godani1, Sanjay Sharma1
1Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS, (Deemed to be University), Vile Parle West, Mumbai, Maharashtra, 400056, India.
Drug metabolism and bioanalysis letters
|July 12, 2024
概括
一种新的紫外线光谱法准确量化了Eltrombopag Olamine,一种治疗血小板缺血和无塑性贫血的药物. 这种简单而经济的方法适用于药品质量控制.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 埃尔特罗姆波帕格 (Eltrombopag Olamine) 是一种用于通过刺激血小板产生来治疗血小板缩和严重无形性贫血的血小板蛋白受体激活剂.
- 拥有可靠的方法来量化Eltrombopag Olamine在散装和制药形式中的可靠方法至关重要.
研究的目的:
- 开发一种简单,具体,准确,精确和经济的紫外线 (UV) 光谱法.
- 为了估计Eltrombopag Olamine在散装药物和片剂剂型中的度.
主要方法:
- 在甲醇中使用紫外线光谱用于药物分析.
- 方法验证包括线性,精度,准确性,特异性,检测极限 (LOD) 和量化极限 (LOQ) 根据ICH Q2 (R2) 指南.
主要成果:
- 观察到的最大吸收波长 (λmax) 在247nm.
- 该方法在2-14μg/ml范围内显示出极好的线性 (r2 = 0.999).
- 获得了高精度 (%回收98-99%) 和精度 (%RSD<2%),LOD为0.0524μg/ml,LOQ为0.1588μg/ml.
结论:
- 开发的紫外线光谱法简单,经济,准确和有选择性.
- 这种经过验证的方法适用于常规质量控制和药物配方中的Eltrombopag Olamine的估计.
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