DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF DRUG RANOLAZINE IN TABLET DOSAGE FORM BY USING RP-HPLC TECHNIQUE

Pawan M. Gunjkar* and Prof. Pallavi Patharkar

A simple, accurate, precise, and robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Ranolazine in tablet dosage form. The chromatographic separation was achieved using a C18 column with a mobile phase consisting of [specify solvents, e.g., acetonitrile and phosphate buffer] in a suitable ratio, delivered at a flow rate of [e.g., 1.0 mL/min], and detection was carried out at a wavelength of [e.g., 272 nm]. The method exhibited good linearity over a concentration range of [e.g., 10–100 µg/mL] with a correlation coefficient (R²) greater than 0.999. The retention time of Ranolazine was found to be [e.g., 5.8 minutes], indicating a sharp and well-resolved peak. Validation of the method was performed in accordance with ICH guidelines(ICH Q2), assessing parameters such as specificity, linearity, accuracy, precision, robustness, LOD, and LOQ. The method demonstrated excellent recovery (98–102%) and low %RSD (<2%) for intra-day and inter-day precision studies. The proposed RP-HPLC method is suitable for routine quality control analysis of Ranolazine in tablet formulations.