Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, 11751 Nasr City, Cairo, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, 11751 Nasr City, Cairo, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2018 Feb 5;190:513-517. doi: 10.1016/j.saa.2017.08.023. Epub 2017 Aug 10.
A spectroflurimetric method has been developed and validated for the selective quantitative determination of ledipasvir in presence of sofosbuvir. In this method the native fluorescence of ledipasvir in ethanol at 405nm was measured after excitation at 340nm. The proposed method was validated according to ICH guidelines and show high sensitivity, accuracy and precision. Furthermore this method was successfully applied to the analysis of ledipasvir in pharmaceutical dosage form without interference from sofosbuvir and other additives and the results were statistically compared to a reported method and found no significant difference.
已开发并验证了一种分光荧光光度法，用于在存在索磷布韦的情况下选择性定量测定来迪派韦索。在该方法中，在 340nm 激发后，在乙醇中测量来迪派韦索的固有荧光在 405nm 处。该方法根据 ICH 指南进行了验证，表现出高灵敏度、准确性和精密度。此外，该方法成功地应用于药物制剂中来迪派韦的分析，没有索磷布韦和其他添加剂的干扰，并且结果与报道的方法进行了统计学比较，没有发现显著差异。
