Department of Chemistry, College of Science, King Saud University, P.O. Box 22452, Riyadh, 11495, Saudi Arabia.
J Fluoresc. 2012 Jan;22(1):9-15. doi: 10.1007/s10895-011-0952-x. Epub 2011 Aug 23.
A simple and sensitive spectrofluorimetric method was developed for the determination of ezetimibe in its pharmaceutical formulations. The proposed method is based on investigation of the fluorescence spectral behavior of ezetimibe in sodium dodecyl sulfate (SDS) micellar system. In aqueous solution of acetate buffer pH 5.0, the fluorescence intensity of ezetimibe was greatly enhanced, 200% enhancement, in the presence of SDS. The fluorescence intensity of ezetimibe was measured at 380 nm after excitation at 268 nm. The fluorescence-concentration plot was rectilinear over the range of 0.03-3.0 μg/mL with lower detection limit of 3.08 × 10(-3) μg/mL. The method was successfully applied to the analysis of ezetimibe in its commercial tablets; the results were in good agreement with those obtained with the reported method. The application of the proposed method was extended to the stability studies of ezetimibe after exposure to different forced degradation conditions, such as acidic, alkaline, photo and oxidative conditions, according to ICH guidelines.
建立了一种简单、灵敏的测定药物制剂中依折麦布含量的荧光分光光度法。该方法基于在十二烷基硫酸钠（SDS）胶束体系中研究依折麦布的荧光光谱行为。在醋酸盐缓冲溶液（pH 5.0）的水溶液中，SDS 的存在极大地增强了依折麦布的荧光强度，增强了 200%。在 268nm 激发下，于 380nm 处测量依折麦布的荧光强度。在 0.03-3.0μg/mL 范围内，荧光浓度图呈线性关系，检测限为 3.08×10(-3)μg/mL。该方法成功地应用于依折麦布商业片剂的分析，结果与报道的方法一致。根据 ICH 指南，该方法还扩展用于依折麦布在不同强制降解条件（如酸、碱、光和氧化条件）下的稳定性研究。
