使用HPLC同时估计菲内伦和卡纳格利弗洛辛:在代谢稳定性研究中的应用
Shivam Rathaur1, Parag Varshney1, Sachin Vishwakarma1
1Division of Pharmaceutics and Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, India.
一种新的HPLC方法准确地测量了Finerenone (FNR) 和Canagliflozin (CFZ) 组合在一起. 这种经过验证的技术是敏感的,可靠的,对于药物代谢研究是有用的.
科学领域:
- 分析化学 分析化学
- 药理学 药理学是指药理学的学科.
- 药物新陈代谢 药物新陈代谢
背景情况:
- 芬 (FNR) 和卡纳格利弗洛辛 (CFZ) 是重要的药物.
- 准确的同时量化这些药物对于研究和开发至关重要.
研究的目的:
- 开发和验证一种强大,灵敏和可靠的高性能液态染色学 (HPLC) 方法,用于同时估计FNR和CFZ.
- 在体外代谢稳定性研究中应用经过验证的方法.
主要方法:
- 在HPLC分析中,使用C18柱与酸移动相:水 (51:49) 在0.75毫升/分钟的流速下进行分析.
- 通过PDA探测器在FNR的249nm和CFZ的290nm处进行检测.
- 方法验证包括具体性,线性,准确性,精度,LOD,LOQ,稳定性和稳定性,根据ICH指南.
主要成果:
- 该方法实现了10.0分钟的运行时间,FNR的保留时间为6.33分钟,CFZ的保留时间为8.26分钟.
- 在0.05-10μg/mL范围内,FNR的R2值为0.998,CFZ的R2值为0.999,线性得到证实.
- 确定了低LOD (0.53微克/毫升用于FNR,0.36微克/毫升用于CFZ) 和LOQ (1.62微克/毫升用于FNR,1.10微克/毫升用于CFZ).
结论:
- 开发的HPLC方法是特定的,简单的,高度敏感的,可靠的,坚固的和可重复的.
- 该方法已成功应用于在各种物种 (人类,子,狗,子,老鼠,小鼠) 的体外代谢稳定性研究中的同时估计.
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