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通过HPLC-DAD和LC-MS/MS在术后止痛溶液中同时确定14种止痛药

Manman Yao^1,2, Baoxia Fang¹, Jinguo Yang¹

¹Sinopharm Dongfeng General Hospital, Hubei University of Medicine, Shiyan, Hubei, 442008, People's Republic of China.

|January 10, 2024

概括

使用HPLC-DAD和LC-MS/MS开发的方法可以准确量化14种止痛药. 这些验证的技术对于检测药物滥用和分析临床环境中的止痛解决方案至关重要.

科学领域:

分析化学分析化学
法医毒理学法医毒理学
药品分析药品分析

背景情况:

精确量化止痛药对于临床实践,药物滥用检测和制药研究至关重要.
现有的方法可能缺乏全面分析所需的灵敏度,效率或范围.
需要验证,绿色和高效的分析技术至关重要.

研究的目的:

开发和验证绿色,高效,敏感和准确的分析方法来量化14种特定的止痛化合物.
建立可靠的临床应用方法,药物滥用查和止痛剂溶液的稳定性/兼容性研究.

主要方法:

具有二极管阵列检测 (HPLC-DAD) 的高性能液态染色学,使用SinoChrom ODS-BP C18柱和二二酸-酸移动相.
液体染色学-并联质谱学 (LC-MS/MS) 使用一个ACQUITY UPLC-BEH C18柱和一个酸-酸移动相.
方法验证是根据国际协调理事会 (ICH) 的指导方针进行的.

主要成果:

通过HPLC-DAD实现了从0.10到20.0μg/mL的量化极限 (LOQ),精度在1.1-2.0% (白天) 和0.4-1.3% (白天) 之间,平均恢复率>98%.
通过LC-MS/MS实现了从0.005到0.2 ng/mL的LOQ量化,精度在1.2-4.1% (白天) 和0.6-3.3% (白天) 之间,平均恢复率>93%.
这两种方法都表现出良好的线性,并在临床环境中成功应用.

结论:

经过验证的HPLC-DAD和LC-MS/MS方法提供了对14种止痛药的准确和敏感量化.
这些方法为临床药物滥用检测和对止痛解决方案的研究提供了强大的技术基础.
开发的分析策略符合严格的验证要求,确保在法医和制药应用中的可靠性.

关键词:

在 HPLC DADAD 中.在 LCMS/MS 中使用.在阿片类药物中,阿片类药物手术后的疼痛术后的疼痛独立的独立的

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