Department of Pharmacognosy and Pharmaceutical Chemistry, College of Pharmacy, Taibah University, Al-Madinah Al-Munawwarah, Saudi Arabia.
Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, Egypt.
Luminescence. 2024 Jul;39(7):e4816. doi: 10.1002/bio.4816.
Bilastine, a new second generation antihistaminic drug, has been widely used for relieving symptoms of allergic rhinitis and urticaria without a sedative effect. A simple, cost-effective, and highly sensitive fluorimetric method was developed for the estimation of bilastine in human plasma, in addition to its pure state and tablets. The suggested method depended on binary complex formation of eosin with bilastine in a buffered medium at pH 4.2. The formed complex resulted in quantitative quenching of eosin emission at 538 nm after excitation at 335 nm. This method demonstrates a broad range of linearity, spanning from 200 to 1000 ng/mL, and exhibits exceptional sensitivity, with a limit of detection and quantitation of 30.85 and 93.48 ng/mL, respectively. In addition, this spectrofluorimetric method may be employed to determine the amount of bilastine in human plasma and tablets with satisfactory accuracy and excellent precision. Furthermore, the content uniformity of bilastine in commercially available tablets was successfully tested by this approach. Compared with the reference method, there were no significant variations in terms of precision or accuracy. In conclusion, the proposed protocol is highly recommended to quantitatively estimate bilastine in different quality control settings.
比拉斯汀是一种新型第二代抗组胺药物，具有缓解过敏性鼻炎和荨麻疹症状而无镇静作用的特点，已被广泛应用。本研究建立了一种简单、经济、高灵敏度的荧光法，用于人血浆中比拉斯汀及其纯品和片剂的测定。该方法基于在 pH 4.2 的缓冲介质中，曙红与比拉斯汀形成二元配合物。形成的配合物在 335nm 激发下，538nm 处的曙红发射强度发生定量猝灭。该方法具有较宽的线性范围（200~1000ng/mL），且灵敏度极高，检测限和定量限分别为 30.85 和 93.48ng/mL。此外，该荧光法可用于测定人血浆和片剂中的比拉斯汀含量，具有满意的准确度和良好的精密度。该方法还成功地用于检测市售片剂中比拉斯汀的含量均匀度。与参比方法相比，该方法在精密度和准确度方面均无显著差异。总之，该方法可用于不同质量控制条件下比拉斯汀的定量测定。
