Luo Kaiwei, Liu Danrui, Zhang Shengshuo, Zhang Xin, Cheng Qunan, Lin Jie, Yu Yonghua
Fuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd, Ningbo, China.
Bioanalysis. 2025 May;17(10):661-669. doi: 10.1080/17576180.2025.2506349. Epub 2025 May 15.
This study aimed to establish a robust LC-MS/MS method for quantifying trazodone in human plasma and investigate its pharmacokinetic profile in healthy Chinese subjects under fasting and fed conditions.
MATERIALS & METHODS: A validated LC-MS/MS method using protein precipitation was applied to analyze trazodone in 68 healthy subjects (34 fasting/34 fed), with full method validation performed.
This method exhibited high selectivity, precision, and accuracy. The results showed good linearity in the range of 5-3000 ng/mL and matrix effect results showed no matrix interference. The pharmacokinetic data revealed notable differences between the fasting and postprandial states.
The validated LC-MS/MS method proved reliable for trazodone quantification. The observed food effects on absorption suggest clinical dosing should consider administration conditions to ensure optimal therapeutic outcomes.
本研究旨在建立一种可靠的液相色谱-串联质谱法(LC-MS/MS)用于定量测定人血浆中的曲唑酮,并研究其在健康中国受试者空腹和进食条件下的药代动力学特征。
采用经过验证的蛋白质沉淀法LC-MS/MS对68名健康受试者(34名空腹/34名进食)的曲唑酮进行分析,并进行了完整的方法验证。
该方法具有高选择性、精密度和准确性。结果显示在5-3000 ng/mL范围内具有良好的线性,基质效应结果表明无基质干扰。药代动力学数据显示空腹和餐后状态之间存在显著差异。
经过验证的LC-MS/MS方法被证明可可靠地定量曲唑酮。观察到的食物对吸收的影响表明临床给药应考虑给药条件以确保最佳治疗效果。