Development and Validation of a New Stability Indicating RP-UFLC Method for the Estimation of Ranolazine Tablets

Abstract

Introduction: Ranolazine is a piperazine derivative used for the treatment of chronic angina (chest pain). It is a
new anti-ischemic drug and can be used alone or with other medications to treat chronic angina (ongoing chest
pain or pressure that is felt when the heart does not get enough oxygen). A new stability indicating RP-UFLC
method has been proposed for the quanification of Ranolazine in pharmaceutical formulations. Shimadzu Model
CBM-20A/20 Alite high performance liquid chromatography system with PDA detector and Agilent C18 column
were used for the chromatographic study. Materials and Methods: Mobile phase mixture consisting of tetra
butyl ammonium hydrogen sulfate and methanol (47:53, v/v) with flow rate 0.8 mL/min was selected for the
chromatographic study of Ranolazine with detection wavelength 215 nm. Results and Discussion: Ranolazine
has shown linearity over the concentration range of 0.1–50 μg/ml with linear regression equation, y = 71784x +
4994.2 (R² = 0.9999). The LOD and LOQ were found to be 0.0319 μg/ml and 0.0981 μg/ml, respectively. Stress
degradation studies were performed by exposing Ranolazine to various stress conditions and the method was
validated as per ICH guidelines.