Helmy S A, El Bedaiwy H M
Department of Clinical and Hospital Pharmacy, Faculty of Pharmacy, Taibah University, AL-Madinah AL-Munawarah, Kingdom of Saudi Arabia.
Department of Pharmaceutics, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.
Biomed Chromatogr. 2016 Jul;30(7):1059-1064. doi: 10.1002/bmc.3650. Epub 2015 Dec 8.
A simple and sensitive method was developed for fexofenadine determination in human plasma by liquid chromatography with ultraviolet detection. Satisfactory separation was achieved on a Hypersil® BDS C18 column (250 × 4.6 mm, 5μm) using a mobile phase comprising 20 mm sodium dihydrogen phosphate-2 hydrate (pH adjusted to 3 with phosphoric acid)-acetonitrile at a ratio of 52:48, v/v. The elution was isocratic at ambient temperature with a flow rate of 1.0 mL/min. The UV detector was set at 215 nm for the drug and 330 nm for the internal standared (tinidazole). The total time for a chromatographic separation was ~6.5 min. Linearity was demonstrated over the concentration range 0.01-4 μg/mL. The observed within- and between-day assay precision ranged from 0.346 to 13.6%; accuracy varied between 100.4 and 111.2%. This method was successfully applied for therapeutic drug monitoring in patients treated with clinical doses of fexofenadine and for pharmacokinetic studies. Copyright © 2015 John Wiley & Sons, Ltd.
建立了一种简单灵敏的液相色谱 - 紫外检测法测定人血浆中盐酸非索非那定。采用Hypersil® BDS C18柱（250×4.6 mm，5μm），以20 mM磷酸二氢钠二水合物（用磷酸调pH至3） - 乙腈（体积比52:48）为流动相，在室温下等度洗脱，流速为1.0 mL/min，实现了满意的分离。紫外检测器对药物设定在215 nm，对内标（替硝唑）设定在330 nm。色谱分离总时间约为6.5分钟。在0.01 - 4μg/mL浓度范围内呈线性。日内和日间测定精密度范围为0.346%至13.6%；准确度在100.4%至111.2%之间变化。该方法成功应用于接受临床剂量盐酸非索非那定治疗患者的治疗药物监测及药代动力学研究。版权所有© 2015 John Wiley & Sons, Ltd.
