A new stability indicating RP-HPLC method for estimation of brexpiprazole

  • Goutham Kumar Vanaplli GITAM UNIVERSITY
  • Sumanta Mondal Department of pharmaceutical analysis & quality assurance, GITAM institute of pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Abstract

A simple stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Brexpiprazole in tablet dosage forms. Reversed-phase chromatography was performed on Shimadzu Model CBM-20A/20 Alite, using a mixture of 0.1% acetic acid and methanol (65:35, v/v) as mobile phase with a flow rate of 0.9 mL/min.  Detection was carried at 214nm. Linearity was observed over the concentration range of 0.1–250 μg/mL (R2 = 0.9999) with regression equation y = 39617.94x + 3300.8. Brexpiprazole was subjected to stress conditions (acidic, alkaline, oxidation and thermal degradation) and validated as per ICH guidelines. The validated method can be applied to perform long-term and accelerated stability studies of Brexpiprazole formulations.


Keywords: Brexpiprazole; Isocratic elution; Reversed-phase HPLC; Stability-indicating; Validation.

Downloads

Download data is not yet available.

Author Biography

Sumanta Mondal, Department of pharmaceutical analysis & quality assurance, GITAM institute of pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Department of pharmaceutical analysis & quality assurance, GITAM institute of pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Statistics
43 Views | 34 Downloads
How to Cite
Vanaplli, G., & Mondal, S. (2019). A new stability indicating RP-HPLC method for estimation of brexpiprazole. Journal of Drug Delivery and Therapeutics, 9(2-s), 214-222. https://doi.org/10.22270/jddt.v9i2-s.2652