Analysis of Tasimelteon in Pharmaceutical Formulations and Bulk Based on Design-Based Quality Approach by HPLC and...

In this study, a straightforward, precise, environmentally friendly, and strong high-performance liquid chromatography technique was established for the examination of Tasimelteon in pharmaceutical formulations. The chemometric factor screening investigation facilitated the identification of crucial technique parameters, which were subsequently improved using the Box-Behnken design to enhance comprehension and enhance the performance of the method. The separation was achieved with using the Supelco Ascentis® Express C8 column (100 × 4.6 mm, id, 2.7 μm) with a mobile phase consisting of methanol:phosphate buffer (0.030 M, pH 2.5) at a ratio of 51:49 (v/v). The flow rate was chosen as 1.2 mL/min. The optimized method was fully validated according to International Council on Harmonization (Q2)R1. The method demonstrated linearity within the concentration range of 10.0 to 75.0 μg/mL, with a coefficient of determination (R2) of 0.999 and a significance level (P) of less than 0.05. Linearity investigations were conducted using the peak normalization approach. The internal standard that was deemed most suitable was agomelatine, at a concentration of 33.0 μg/mL. In addition, the environmental sustainability of the method was proved using different analytical greenness metrics as National Environmental Methods Index, analytical eco-scale, Analytical Greenness Metric and Green Analytical Procedure Index for evaluating its greenness. The applicability of the method was demonstrated in the analysis of Hetlioz® pseudo formulation.