Quality by design approach for the analysis of tasimelteon inpharmaceutic products with HPLC

Today, the views of pharmaceutical regulatory and experts are that there is an increasing need for the systematic approaches in the pharmaceutical quality control system. Quality control methods play an important role in the control strategy to ensure the quality of pharmaceutical production. In particular, the increasing need for quality control methods, analysis load, and the need for long analysis times due to the nature of some active substances necessitate that the process be more efficient. It is undeniable that statistical methods are the biggest supporters of the analyst here. For the applied more, it is important that they become systematic and support analyst knowledge. In this study, a simple, sensitive, green, and robust high-performance liquid chromatography (HPLC) method was developed for the analysis of Tasimelteon (TSM) in pharmaceutical preparations. The chemometric factor screening study helped identify critical method parameters that were optimized using the Box-Behnken design for better understanding and improvement of method performance. Chromatographic separation, Supelco Ascentis® Express C8 (100×4.6 mm, ID, 2.7µm) using methanol:phosphate buffer (0.030 M, pH 2.5):(51:49, v/v) as mobile phase and it was performed at 1.2 mL/min flow rate. Linearity of the method was observed for concentrations of 10.0 to 75.0 µg/mL (R2 = 0.999, p<0.05). The peak normalization technique was applied for linearity studies. For this purpose, the most appropriate internal standard was chosen as agomelatine, and its concentration was found to be 33.0 µg/mL. Accuracy evaluation was achieved in the range of 95.9–100%. Additionally, the greenness of the method was demonstrated using various analytical greenness evaluation metrics.