Ahmed Ahmed S, Badr El-Din Khalid M, Khorshed Ahmed A, Derayea Sayed M, Oraby Mohamed
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Sohag University, Sohag, 82524, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia, 61519, Egypt.
BMC Chem. 2025 Aug 31;19(1):258. doi: 10.1186/s13065-025-01622-y.
Bilastine (BIL) is a new second-generation antihistaminic drug used for the management of urticaria and rhino-conjunctivitis symptoms. Herein, a spectrofluorimetric method for determining BIL is described. The method is very sensitive, simple, quick, and green. The suggested method depended on the measurement of the original fluorescence of BIL in 1.0 M sulfuric acid at an emission wavelength of 385 nm after an excitation at 272 nm. The method was evaluated by the International Council on Harmonization (ICH) requirements. The relationship between BIL concentrations and the fluorescence intensities was linear in a range of 10.0-500.0 ng mL, and the correlation coefficient was 0.9999. The detection limit was 2.9 ng mL and the quantitation limit was 8.8 ng mL. The suitable sensitivity and selectivity of the suggested method enabled its application successfully in analyzing BIL in pharmaceutical tablets without any interfering effect from their excipients and in spiked human plasma with appropriate recoveries from 95.72 to 97.24%. Additionally, the suggested method was utilized for content uniformity testing.
比拉斯汀（BIL）是一种新型第二代抗组胺药物，用于治疗荨麻疹和鼻结膜炎症状。本文描述了一种测定比拉斯汀的荧光分光光度法。该方法非常灵敏、简单、快速且环保。所建议的方法基于在272nm激发后，于1.0M硫酸中在385nm发射波长处测量比拉斯汀的原始荧光。该方法按照国际协调理事会（ICH）的要求进行了评估。比拉斯汀浓度与荧光强度之间在10.0 - 500.0 ng/mL范围内呈线性关系，相关系数为0.9999。检测限为2.9 ng/mL，定量限为8.8 ng/mL。所建议方法具有合适的灵敏度和选择性，能够成功应用于分析药物片剂中的比拉斯汀，不受其辅料的干扰，并且能够成功应用于加标的人血浆分析，回收率在95.72%至97.24%之间。此外，所建议的方法还用于含量均匀度测试。
