NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF UV -VISIBLE SPECTROSCOPY AND USING FTIR STUDY OF CHEMICAL STRUCTURE OF VORTIOXETINE HYDROBROMIDE

Nandankumar K.*, Mr. Sumanth S., Ms. Sonalika Y. S., Ms. Vinutha Y.

ABSTRACT

Creation and application of a straightforward, accurate, and precise zero order spectroscopic technique for the measurement of vortioxetine HBR in tablet and bulk dose forms. According to Beer's law, the drug shows the maximum absorption (λmax) at 227 nm in ethanol solutions, and the absorption spectrum's AUC is measured in the wavelength range of 222 to 232 nm at concentrations between 4 and 20 µg/ml. A linearity analysis revealed an R2 of 0.9996. The results showed that the LOD and LOQ were 1.809 and 5.484µg/ml, respectively. It was discovered that the %RSD was less than 2%. According to ICH criteria, the method has been verified for linearity, precision, accuracy, robustness, ruggedness, LOD, and LOQ. This approach complies with Beer's law and satisfies all necessary requirements within the constraints. The active pharmaceutical substance Vortioxetine HBr has distinct wave number peaks according to FTIR research. In addition to meeting the necessary requirements, FTIR data interpretation provides information on the sample's quality and purity.

Keywords: Vortioxetine HBr, UV Spectroscopy, FTIR, ICH Guidelines.