开发和验证新型HPLC方法,以量化确定平板剂型维生素D3的剂量
Muhammad Saqib Gohar1, Taj Ur Rahman1, Ali Bahadur2
1Department of Chemistry, Mohi-Ud-Din Islamic University, Nerian Sharif, Azad Jammu & Kashmir 12080, Pakistan.
Pharmaceuticals (Basel, Switzerland)
|April 27, 2024
概括
一种高效的高性能液态染色法 (HPLC) 方法准确地量化了片中的维生素D3. 这种经过验证的方法为例行分析提供了精确可靠的结果,确保了维生素D3补充剂的质量控制.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 准确量化维生素D3对于药品质量控制至关重要.
- 现有的方法可能需要优化以进行常规的药片分析.
研究的目的:
- 开发和验证一种高效的同位素高性能液体染色学 (HPLC) 方法,用于估计片剂型维生素D3的剂量.
主要方法:
- 使用L3柱与n-hexane/乙烯酸移动相.
- 使用流量为2.0毫升/分钟,在292纳米处检测.
- 根据USP/BP和ICH准则验证了方法的准确性,精度,特异性和稳定性.
主要成果:
- 实现了高线性 (R2 = 0.999) 和可接受的相对标准偏差 (RSD) 值,用于流速 (0.81%) 和移动相组合 (0.72%).
- 确定了0.0539微克/毫升的低检测极限 (LOD) 和0.1633微克/毫升的量化极限 (LOQ).
- 已证明可接受的日内和日间精度 (% RSD).
结论:
- 开发的同位素HPLC方法是精确的,准确的,和强大的维生素D3量化在片中.
- 这种经过验证的方法适用于药品配方中维生素D3的常规质量控制分析.
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