Abstract

STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION OF VERICIGUAT IN TABLET DOSAGE FORM

Prajapati Foram* and Priyanka Yadav

ABSTRACT

The present study was focused to develop a simple, precise, accurate and cost effective stability indicating HPLC method development and validation of vericiguat in tablet dosage form. The chromatographic method was carried out using Zorbax SB C18 (250mm*4.6mm), 5μm column with mobile phase Phosphate buffer (pH 4.3 adjusted with 0.1% OPA): Acetonitrile in ratio of 40:60%v/v. The flow rate was set 1.0ml/min with 20μL injection volume. Total run time 14 min. Detection was carried out at the wavelength of 307nm. The detector response was linear in the concentration range of 150-50μg/ml with a correlation coefficient of 1 for vericiguat respectively. The developed analytical method was validated according to the ICH guideline. vericiguat was also subjected to various stress condition like acid and alkali hydrolysis, oxidation, photolysis and thermal degradation. The developed method is successfully applied for estimation of vericiguat in tablet dosage form.

Keywords: Vericiguat, HPLC, Method development, Stability study, Validation.