NEW SPECTROPHOTOMETRIC TECHNIQUES FOR THE ESTIMATION OF BREXPIPRAZOLE IN TABLET DOSAGE FORMAbstract
Brexpiprazole is an atypical antipsychotic drug indicated for the treatment of schizophrenia. Four novels, simple, precise and accurate spectrophotometric methods were developed for the determination of Brexpiprazole (Rexulti) in pharmaceutical dosage forms. The absorption maxima was found to be at 214 nm in method A (0.1N HCl) and shows linearity over the concentration range of 0.002-0.02 µg/mL with regression equation 15.4517x + 0.0221 (r2 = 0.9990). In Method B (Sodium acetate buffer, pH 4.5) the drug obeys Beer Lambert’s law (λmax214 nm) in the concentration range of 0.005-0.1 µg/mL with regression equation 23.457x – 0.0235 (r2= 0.9992). First derivative spectrophotometric methods (C and D) were developed in 0.1N HCl and sodium acetate pH 4.5 in which Brexpiprazole obeys Beer Lambert’s law 0.002-0.02 µg/mL and 0.005-0.1 µg/mL with regression equations 4.9605x + 0.0003 and 1.9990x – 0.0009 respectively. The proposed spectrophotometric methods were validated as per the ICH guidelines and can be applied for the determination of Brexpiprazole in pharmaceutical formulations.
S. Mondal *, V. G. Kumar and P. Mondal
Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam, Andhra Pradesh, India.
05 September 2018
06 November 2018
12 November 2018
01 May 2019