Stability indicating method development and validation of ranolazine extended release tablets

Abstract

© 2021, Istanbul Medipol University. All rights reserved.The objective of this study was to develop and validate the stability-indicating method for newly developed Extended-Release tablet formulation of Ranolazine. First, new Ranola-zine tablet formulation was developed. These tablets were analyzed by using a High-Per-formance Liquid Chromatography system with a UV detector at 220 nm wavelength and by using C8-3 column (150 mm x 4.6 mm i.d; 5 µm particle size). The injection volume of the system was 10 µl. The validation parameters; Selectivity, linearity, accuracy, robust-ness, precision and limit of quantification and detection parameters were proved good re-sults. A highly sensitive and simple HPLC-UV analytical method of the Ranolazine tablet formulation was developed in accordance with ICH Guideline Q2 and Q3.