使用RP-HPLC方法开发和验证液体剂量形式的酸的方法
Aavula Roja1, Peram Uma Maheshwari1, Ramapuram Munemma1
1Pharmaceutical Analysis, Institute of pharmaceutical technology, Sri Padmavathi Mahila Visvavidyalayam, Tirupathi, India.
Advances in experimental medicine and biology
|August 15, 2023
概括
一种新的反相高性能液态色谱 (RP-HPLC) 方法提供了一种简单,快速和灵敏的方法来量化制药产品中的酸. 这种经过验证的方法确保了质量控制的准确分析.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 酸是各种制药配方中的关键化合物.
- 准确量化酸对于药物质量控制和疗效至关重要.
研究的目的:
- 开发和验证一种简单,快速,精确,灵敏和可重复的RP-HPLC方法来量化酸.
- 确保该方法适用于药物剂量形式的常规分析.
主要方法:
- 使用水域X-Terra RP-18列进行RP-HPLC分离.
- 移动阶段:0.1%的酸和乙二 (70:30 v/v) 在 1.0 mL/min 的流量下.
- 在275nm使用光二极管阵列探测器进行检测.
主要成果:
- 该方法以NLT 2000理论板和尾部系数 ≤ 2 实现了出色的染色分离.
- 峰值区域的相对标准偏差始终为<2.0%.
- 根据ICH指南的方法验证证实了其精度,准确性和稳定性.
结论:
- 开发的RP-HPLC方法简单,经济,适合对酸进行定量分析.
- 这种经过验证的方法为制药品质量控制提供了可靠的工具.
- 该试验显示了高灵敏度和可重复性,用于酸的确定.
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