Development and Validation of a New UV-Spectroscopic Method for the Estimation of Vortioxetine Hydrobromide in Bulk and Pharmaceutical Formulation

Background

Major depressive disorders are treated with the antidepressant vortioxetine. In the current work, UV-Vis Spectroscopy was used to establish a new, simple, reliable, precise, selective, and ecologically sound approach for determining vortioxetine in bulk and pharmaceutical formulation.

Materials and Methods

A novel UV-Spectrophotometric method was developed using Shimadzu UV-1800 Spectrophotometer, the diluent was composed of 20% methanol and 80% water and the wavelength was set 225nm based on the highest absorbance exhibited vortioxetine hydrobromide. According to ICH Q2R2 guidelines, the method's linearity, precision, robustness, ruggedness, limit of detection and limit of quantitation, accuracy, and assay were all verified.

Results and Discussion

With a correlation coefficient (R²) of 0.9997, the technique complies with Beer-Lambert's law in the concentration range of 2 to 10 µg/mL. By calculating the percentage relative standard deviation of less than 2%, the approach demonstrated exceptional precision, durability, and ruggedness. The assay result was 99.08% and the method demonstrated an outstanding recovery between 100.28% to 102.60%. The eco-friendliness of the method was assessed using AGREE software with the score of 0.9.

Conclusion

Therefore, for the routine and systematic examination of vortioxetine hydrobromide, the developed and validated method was proved to be having a number of benefits.