Stability indicating method development and validation of ranolazine extended release tablets


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Durak E. A., Kurtgöz İ., MESUT B., CEVHER E., Özsoy Y.

Acta Pharmaceutica Sciencia, vol.59, no.3, pp.419-434, 2021 (Scopus) identifier

  • Publication Type: Article / Article
  • Volume: 59 Issue: 3
  • Publication Date: 2021
  • Doi Number: 10.23893/1307-2080.aps.05925
  • Journal Name: Acta Pharmaceutica Sciencia
  • Journal Indexes: Scopus, EMBASE
  • Page Numbers: pp.419-434
  • Keywords: Forced degradation, HPLC, Ranolazine, Stability indicating method, Validation
  • Istanbul University Affiliated: Yes

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.