Aim: A new, accurate and sensitive reversed-phase high-performance liquid chromatography (RP-HPLC) as an analytical method for the quantitative determination of eight antifungal drugs in spiked human plasma has been described optimized and validated.

Materials and Methods: The analyzed compounds were voriconazole (VOR), luliconazole (LUL), clotrimazole (CLO), tioconazole (TIO), posaconazole (POS), ketoconazole (KET), sertaconazole (SER) and terconazole (TER).

Results: The separation of the analyzed compounds was conducted using a novel pentabromobenzyl column known as COSMOSIL PBB-R (150 mm × 4.6 mm I.D., particle size 5 μm). The analysis of the studied drugs was determined within 14 min using a diode array detector and the mobile phase consisted of: 10 mM potassium dihydrogen phosphate buffer (pH 2.1): Methanol (2: 98 v/v). A linear response was observed for all compounds in the range of concentration studied. Sample preparation was done through liquid-liquid extraction using diethyl ether.

Conclusion: This proposed method was validated in terms of linearity, limit of quantification, limit of detection, accuracy, precision and selectivity. The method was successfully applied for the determination of these drugs in their pharmaceutical formulations and in human plasma samples.

目的：已经优化和验证了一种新型，准确，灵敏的反相高效液相色谱（RP-HPLC）作为定量测定加标人血浆中八种抗真菌药物的分析方法。

材料和方法：被分析的化合物为伏立康唑（VOR），卢立康唑（LUL），克霉唑（CLO），噻康唑（TIO），泊沙康唑（POS），酮康唑（KET），舍他康唑（SER）和特康唑（TER）。

结果：使用新型五溴苄基色谱柱（COSMOSIL PBB-R，150 mm×4.6 mm ID，粒径5μm）进行分析化合物的分离。使用二极管阵列检测器在14分钟内确定了研究药物的分析，流动相包括：10 mM磷酸二氢钾缓冲液（pH 2.1）：甲醇（2：98 v / v）。在所研究的浓度范围内，所有化合物均观察到线性响应。通过使用乙醚的液-液萃取完成样品制备。

结论：该方法在线性，定量限，检测限，准确度，精密度和选择性方面得到了验证。该方法已成功用于测定这些药物在其药物制剂和人血浆样品中的含量。