With the aim of studying the pharmacokinetics of letermovir, which is a newly developed antiviral agent for human cytomegalovirus, a rapid and simple ultra-performance liquid chromatography coupled with mass spectrometry (UPLC/MS) method was developed and validated for the quantification of letermovir in human plasma. Separation was performed in reverse phase mode using an ACQUITY UPLC BEH C18 column (130 Å, 1.7 µm, 2.1 × 50 mm) at a flow rate of 0.3 mL/min, 10 mM ammonium acetate–0.1% formic acid solution as mobile phase A, and acetonitrile as mobile phase B with a gradient elution. The method was validated over a linear range of 10–1000 ng/mL with a coefficient of determination (R²) >0.99 using weighted linear regression analysis. The intra- and inter-assay accuracy (nominal%) and precision (relative standard deviation%) were within ±15 and ≤15%, respectively. The specificity, recovery, matrix effect, stability, and dilution integrity of this method were also within acceptable limits. This method could be useful in studying the pharmacokinetics and pharmacodynamics, as well as performing the therapeutic drug monitoring of letermovir.

为了研究莱特莫韦（一种新开发的抗人巨细胞病毒抗病毒药物）的药代动力学，开发了一种快速、简单的超高效液相色谱联用质谱 (UPLC/MS) 方法，并验证了莱特莫韦在人血浆。使用 ACQUITY UPLC BEH C18 色谱柱（130 Å，1.7 µm，2.1 × 50 mm）以反相模式进行分离，流速为 0.3 mL/min，10 mM 醋酸铵–0.1% 甲酸溶液作为流动相 A ，乙腈作为流动相 B，梯度洗脱。该方法在 10–1000 ng/mL 的线性范围内进行了验证，确定系数 ( R ²) >0.99 使用加权线性回归分析。批内和批间准确度（标称%）和精密度（相对标准偏差%）分别在±15%和≤15%以内。该方法的特异性、回收率、基质效应、稳定性和稀释完整性也在可接受的范围内。该方法可用于研究莱特莫韦的药代动力学和药效学，以及进行治疗药物监测。