Roshdy Aya, Elmansi Heba, Shalan Shereen, El-Brashy Amina
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Horus University-Egypt, New Damietta, Egypt.
R Soc Open Sci. 2021 Feb 17;8(2):202130. doi: 10.1098/rsos.202130.
A 2 full factorial design model was used for the development of a new high performance liquid chromatography method with UV detection to estimate three antifungal drugs simultaneously. Fluconazole (FLU), itraconazole (ITR) and terbinafine (TRH) are co-administered for severe fungal infections. They have been determined using MOS-1 Hypersil C column and an isocratic eluent; methanol 95% and phosphate buffer 5% with 0.001% triethylamine. The pH was adjusted to 7, and the flow rate was 0.7 ml min. The three drugs were separated within less than 7 min at 210 nm. The developed method gave a linear response over 5-80 µg ml, 5-50 µg ml and 1-50 µg ml for FLU, ITR and TRH, respectively. It showed detection limits of 0.88, 0.29 and 0.20 µg ml and quantification limits of 2.66, 0.88 and 0.60 µg ml for the three drugs, respectively. The design of the experiment facilitated the optimization of different variables affecting the separation of the three drugs. The sensitivity of the designed method permitted the simultaneous estimation of ITR and TRH in spiked human plasma successfully.
采用二因素全因子设计模型开发了一种新的高效液相色谱法，该方法利用紫外检测同时测定三种抗真菌药物。氟康唑（FLU）、伊曲康唑（ITR）和特比萘芬（TRH）联合用于严重真菌感染。使用MOS-1 Hypersil C柱和等度洗脱液进行测定；洗脱液为95%甲醇和5%磷酸盐缓冲液，含0.001%三乙胺。将pH值调至7，流速为0.7 ml/min。三种药物在210 nm波长下于7分钟内分离。所开发的方法对氟康唑、伊曲康唑和特比萘芬分别在5 - 80 μg/ml、5 - 50 μg/ml和1 - 50 μg/ml范围内呈线性响应。三种药物的检测限分别为0.88、0.29和0.20 μg/ml，定量限分别为2.66、0.88和0.60 μg/ml。实验设计有助于优化影响三种药物分离的不同变量。所设计方法的灵敏度能够成功地同时测定加标人血浆中的伊曲康唑和特比萘芬。
