已验证的同位素稳定性指示RP-HPLC方法用于在生物可用性研究中使用的药物产品中的并发雷美西维尔估计
Muhammad Ibrahim1, Muhammad Irfan1, Syed Haroon Khalid2
1Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Government College University Faisalabad, Pakistan.
Pakistan journal of pharmaceutical sciences
|October 26, 2025
概括
一种新的稳定性指示RP-HPLC方法准确量化了各种药物形式和生物样本中的雷梅西维尔 (RMD). 这种经过验证的方法对于RMD配方的质量控制和生物利用性研究至关重要.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 准确量化像remdesivir (RMD) 这样的抗病毒药物对于制药开发和临床使用至关重要.
- 需要强大的分析方法来评估药物稳定性和生物可用性在各种配方和生物矩阵.
研究的目的:
- 开发和验证一种稳定性指示的,同位素逆相高性能液体染色学 (RP-HPLC) 方法用于雷梅西维尔 (RMD) 分析.
- 确保该方法适用于制药配方和生物可用性研究的定量分析,包括复杂矩阵.
主要方法:
- 采用同位素RP-HPLC系统,使用C-18柱和1%三酸和酸 (55:45) 的移动相.
- 使用1毫升/分钟的流量和254纳米的检测,使用可变波长探测器 (VWD).
- 根据当前的良好制造实践 (cGMP) 验证了该方法,包括线性,特异性,精度,准确性,稳定性和强制性降解研究.
主要成果:
- 该方法证明了RMD的一致的保留时间,检测极限 (LOD) 为0.73μg/mL,量化极限 (LOQ) 为2.22μg/mL.
- 在12-120μg/mL的度范围内实现了优异的线性 (R2 = 0.999).
- 稳定性研究证实该方法能够在没有干扰的情况下检测降解产品,这表明其特异性很高.
结论:
- 开发的稳定性指示RP-HPLC方法是精确的,准确的,和强大的定量分析的remdesivir.
- 这种经过验证的分析技术适用于RMD制药配方的常规质量控制以及药理动力学和体内生物可用性研究.
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