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开发一种新的光谱光度测量方法,用于量化大批量和制药剂量形式的desidustat

Sanjay Sharma¹, Sunidhi Jain¹

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

|August 29, 2023

概括

开发了一种新的分析方法来量化消毒剂 (DES),一种用于慢性病患者贫血的低氧诱导因子 (HIF) 抑制剂. 这种简单而敏感的方法适用于药物监测和质量控制.

科学领域:

药品分析药品分析
分析化学分析化学
药物开发药物开发

背景情况:

德西杜沙特 (DES) 是一种新型的低氧诱导因子 (HIF) 酸酶抑制剂.
它用于治疗与慢性病相关的贫血.
对于DES药物估计,目前还没有确立的方法.

研究的目的:

开发一种简单,精确和准确的DES分析方法.
在散装和制药剂型中量化DES.

主要方法:

使用甲醇进行物理化学表征.
根据ICH Q2标准进行验证,包括特异性,线性,准确性,精度,LOD,LOQ和稳定性.

主要成果:

在229nm的最大吸收度;稳定溶液12小时.
在212μg/ml (r2 = 0.9963) 之间观察到线性反应.
准确度:100101%;精度:<2%;LOD:0.434μg/ml;LOQ:1.316μg/ml. 这种测试方法的准确度是100101%;精度:<2%;LOD:0.434μg/ml;LOQ:1.316μg/ml. 这种测试方法的精度是100101%;精度:<2%;LOD:0.434μg/ml;LOQ:1.316μg/ml.

结论:

开发的方法有利于药物监测和分析.
适用于研究和质量控制实验室.
这种方法简单,精确,快速,经济,敏感.

关键词:

他们决定重建国家.紫外线光谱光度测法分析分析分析贫血贫血是一种疾病.开发方法开发方法的方法.验证验证的时间

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