Abstract

METHOD DEVELOPMENT AND VALIDATION OF BREXPIPRAZOLE BY USING SPECTROSCOPIC AND CHROMATOGRAPHIC METHOD

Sanuli V. Poulkar*, Sangram U. Deshmukh, Dhanraj N. Wasmate and Shyamalila B. Bavage

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Abstract

Brexpiprazole is an antipsychotic medication. It works by changing the actions of chemicals in the brain. Brexpiprazole is used to treat the symptoms of schizophrenia. It is also used together with other medications to treat major depressive disorder in adults. Brexpiprazole is a novel D2 dopamine and serotonin 1A partial agonist, called serotonin-dopamine activity modulator (SDAM). Brexpiprazole is non hygroscopic, with white to off-white crystals or crystalline powders, and a melting point of 178-181°C (decomposition). It is practically insoluble in water. Present investigation involves the development and validation of chromatographic method for brexpiprazole in bulk drug as per ICH guideline. The spectrophotometric determination was performed in UV Model: UV- Labman 1900 separation was conducted by using mobile phase consisting of Formic Acid and Methanol (50:50) The wavelength was found at wavelength 218 nm.

Keywords: Brexpirazole, UV, HPLC, Method validation.