Faculty of Pharmacy, Pharos University, Smouha, Alexandria, Egypt.
Faculty of Pharmacy, Damanhur University, Damanhur, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2021 Apr 15;251:119412. doi: 10.1016/j.saa.2020.119412. Epub 2020 Dec 31.
A rapid, cost effective, simple and reliable method was developed for the determination of Tianeptine (TIA) drug in bulk and in pharmaceutical formulation. The fluorescence of Vilazodone was measured in isopropanol at room temperature. The method was optimized by measuring the factors that may affect the fluorescence intensity such as: pH, diluting solvent, temperature and mixing time. The developed method was validated according to ICH guidelines in terms of accuracy, precision, linearity, range, LOD and LOQ. The concentration range was found to be linear in the range of 10-100 ng/ml. The LOD and LOQ values were found to be very small (1.86, 5.62 ng/mL. The % RSD and the % R were found within the acceptable range. Unlike the HPLC procedures, the proposed method for TIA determination has many advantages over the reported analytical methods represented in its rapidity, lower cost and environmental safety as the instrument is simple with low operating cost.
建立了一种快速、经济、简便、可靠的方法,用于测定原料药和药物制剂中的丁螺环酮(TIA)。在室温下,异丙醇中测定了维拉唑酮的荧光。通过测量可能影响荧光强度的因素,如 pH 值、稀释溶剂、温度和混合时间,对方法进行了优化。根据 ICH 指南,对该方法的准确性、精密度、线性、范围、LOD 和 LOQ 进行了验证。在 10-100ng/ml 范围内,浓度与线性度呈线性关系。LOD 和 LOQ 值很小(1.86、5.62ng/ml)。RSD%和 R%均在可接受范围内。与 HPLC 方法不同,所提出的 TIA 测定方法具有许多优点,优于已报道的分析方法,其快速、低成本和环境友好,因为仪器简单,运行成本低。