Background: Terbinafine is an allylamine antifungal that is effective against many fungi, dermatophytes and moulds. Analytical methods are required for the determination of terbinafine in biological fluids to perform therapeutic drug monitoring and pharmacokinetic studies.

Objective: The aim of this study was to develop and validate a novel and fast method combining dilute and shoot approach and high-performance liquid chromatography coupled with photodiode array detection for the determination of terbinafine in human urine.

Methods: Chromatographic parameters including mobile phase composition, pH, flow rate and injection volume were assessed and optimized. The separation of terbinafine and naproxen (internal standard) was achieved within 3 min using a C18 core-shell column (Raptor ARC-18, 100 x 4.6 mm, 2.7 μm) under isocratic conditions. Samples were eluted from the column at the flow rate of 1.4 mL/min using a mobile phase containing 0.2% triethylamine in water (pH 3.4 with formic acid): acetonitrile (45:55, v/v).

Results: The presented technique was linear in the range of 25-2000 ng/mL. Intra- and inter-day reproducibility at four quality control levels (25, 200, 750 and 1500 ng/mL) were less than 7%, with relative errors ranging from -5.40% to 5.91%. The limit of detection was 12.60 ng/mL. The developed method has three main advantages compared to existing methods: simplicity and greenness of sample preparation, use of core-shell column and short analysis time.

Conclusion: The results of this study indicate that the combination of dilute and shoot approach and core-shell column can be regarded as an advantageous application for the fast determination of terbinafine in the urine.

背景：特比萘芬是一种烯丙胺抗真菌剂，对许多真菌、皮肤癣菌和霉菌有效。需要使用分析方法来测定生物体液中的特比萘芬，以进行治疗药物监测和药代动力学研究。

目的：本研究的目的是开发和验证一种新的、快速的方法，将稀释和喷射法与高效液相色谱结合光电二极管阵列检测相结合，用于测定人尿中特比萘芬的含量。

方法：评估和优化色谱参数，包括流动相组成、pH、流速和进样量。使用 C18 核壳柱（Raptor ARC-18，100 x 4.6 mm，2.7 μm）在等度条件下，在 3 分钟内实现特比萘芬和萘普生（内标）的分离。使用含有 0.2% 三乙胺水溶液（pH 3.4，甲酸）：乙腈（45:55，v/v）的流动相以 1.4 mL/min 的流速从柱上洗脱样品。

结果：所提出的技术在 25-2000 ng/mL 范围内呈线性。四个质量控制水平（25、200、750 和 1500 ng/mL）的日内和日间重现性小于 7%，相对误差范围从 -5.40% 到 5.91%。检测限为 12.60 ng/mL。与现有方法相比，所开发的方法具有三个主要优点：样品制备简单、绿色环保、使用核壳柱和分析时间短。

结论：本研究结果表明，稀释和芽法与核壳柱相结合可作为快速测定尿液中特比萘芬的有利应用。