RESUMO
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.
Assuntos
Tiazepinas , Cloridrato de Vilazodona , Cromatografia Líquida de Alta Pressão , Espectrometria de FluorescênciaRESUMO
A reliable, sensitive, simple and inexpensive spectrofluorimetric method has been developed for assay of mirabegron in bulk powder and in its tablets. The method depends on the quenching effect of mirabegron on the fluorescence intensity of acetoxymercuric fluorescein (AMF) reagent at Æem of 520â¯nm and Æex of 498â¯nm. Parameters that may affect the reaction such as pH, AMF solution concentration, temperature, time and diluting solvents were studied and optimized. Under the optimized conditions, the proposed method was applied over the concentration range of 1-5⯵gâ¯mL-1 with acceptable linearity (râ¯=â¯0.9997). The developed method was validated according to ICH guidelines in terms of accuracy, precision, linearity, range, LOD and LOQ. The proposed method was applied to analyze mirabegron in Bladogra® 50â¯mg tablets with acceptable recovery% of 100.41 and RSD% of 1.72. The results obtained were compared to those obtained by a previously reported TLC method.