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开发和验证一种简单的HPLC-UV方法,用于在散装药物和制药剂量形式中确定阿莫西西林三水合物

Tite Uwambajineza¹, Thomas Bizimana²

¹Rwanda FDA-Quality Control Lab, Ministry of Health, Kigali, Rwanda.

Rwanda journal of medicine and health sciences..

|July 16, 2025

概括

这项研究开发了一种负担得起和环保的HPLC-UV方法,使用甲醇进行阿莫西西林分析. 验证的方法是准确的,精确的,适合药品质量控制.

科学领域:

分析化学分析化学
药品分析药品分析

背景情况:

传统的阿莫西西林三水合物测试方法往往依赖于昂贵且对环境有害的乙尼.
药典方法 (例如,USP,BP) 通常使用乙尼,造成成本和环境挑战.

研究的目的:

开发和验证一种具有成本效益,准确,精确和环保的高性能液态染色学与紫外线检测 (HPLC-UV) 方法来确定阿莫西西林.
为了提高可持续性和可负担性,在移动阶段用甲醇取代乙二作为有机溶剂.

主要方法:

开发和验证使用甲醇作为有机溶剂的HPLC-UV方法.
评估方法的特异性,线性,精度 (可重复性) 和准确性.
在制药配方中对阿莫西西林三水合物的分析.

主要成果:

开发的方法表现出极好的特异性,在阿莫西西林保留时间 (3.53 ± 0.020分钟) 上没有干扰的峰值.
在20-160μg/ml范围内证实了线性,相关系数 (r2) 为0.9998.8.
实现了高精度的%RSD值为0.3% (日内) 和0.7% (日间),远低于≤2%的可接受限度.
该方法表现出很好的准确性,平均百分比恢复率为100.5±3.6%.

结论:

一种简单,负担得起,选择性,特异性,快速,灵敏,可重复和准确的HPLC-UV方法成功开发和验证.
这种使用甲醇的环保方法适用于药物剂型中氨基三水合物的常规质量控制.

关键词:

阿莫西西林三水合物在HPLC-UV中使用.验证验证验证验证

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