Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt (BUE), Cairo, Egypt.
Health Research Center of Excellence, Drug Research and Development Group, Faculty of Pharmacy, The British University in Egypt, Cairo, Egypt.
Sci Rep. 2024 Jan 30;14(1):2439. doi: 10.1038/s41598-024-52664-6.
Vilanterol is a once-daily dose inhaler prescribed for asthma and chronic obstructive pulmonary disease. This study involved an investigation of vilanterol stability under acidic, basic, oxidative, thermal, and photolytic stress conditions. UPLC method was developed and validated for the analysis of vilanterol with its degradants. The drug was stable under photolytic and thermal stress conditions and degraded under acidic, basic, and oxidative stress conditions. Degradation kinetics was performed for acidic, basic and oxidative stress conditions. Kinetics parameters, K, half-life time (t) and shelf-life time (t) were assessed, and the degradation followed first order reaction. The method was linear from 0.10 to 100.00 µg mL with accuracy, inter-day and intra-day precision from 99.45 to 100.02%, 0.391-0.694 and 0.041-0.345, respectively. Mass spectrometry was employed to elucidate the structure of the degradants, and the results revealed that certain degradation products were comparable to vilanterol metabolites. The World Anti-Doping Agency has prohibited the presence of vilanterol and its metabolites in athletes' urine except for exercise bronchoconstriction with limited dose. So, quantification of vilanterol in the presence of its degradants was performed in human urine. The results revealed that the method was linear in range of 1.00 to 100.00 µg mL. Samples collection and experimental protocol was performed according to the guidelines of the Research Ethics Committee of the Faculty of Pharmacy, the British University in Egypt with approval No. CH-2305.
维兰特罗是一种每日一次剂量的吸入器，用于治疗哮喘和慢性阻塞性肺疾病。本研究调查了维兰特罗在酸性、碱性、氧化、热和光解应激条件下的稳定性。建立了 UPLC 方法，并对维兰特罗及其降解产物进行了分析验证。药物在光解和热应激条件下稳定，在酸性、碱性和氧化应激条件下降解。对酸性、碱性和氧化应激条件下的降解动力学进行了研究。评估了动力学参数 K、半衰期 (t) 和货架期 (t)，并发现降解遵循一级反应。该方法在 0.10 至 100.00µg mL 范围内呈线性，日内和日间精密度分别为 99.45%至 100.02%、0.391%至 0.694%和 0.041%至 0.345%。采用质谱法阐明了降解产物的结构，结果表明某些降解产物与维兰特罗代谢物相似。世界反兴奋剂机构禁止运动员尿液中存在维兰特罗及其代谢物，除非是在有限剂量下运动引起的支气管收缩。因此，在存在降解产物的情况下对人体尿液中的维兰特罗进行了定量分析。结果表明，该方法在 1.00 至 100.00µg mL 范围内呈线性。样品采集和实验方案是根据埃及英国大学药学院研究伦理委员会的指导方针进行的，批准号为 CH-2305。
