Analytical method validation of ranolazine tablets by RP-HPLC

Ranolazine is a novel anti-anginal drug used in the treatment of chronic stable angina in adults. The present study was designed with an objective to develop and validate a simple, fast, precise, selective and accurate Reverse phase high performance liquid chromatography (RP-HPLC) method for quantitative estimation of Ranolazine in bulk drugs and in selected dosage forms. The efficient chromatographic separation was achieved on a SunShell C₁₈ column (150mm X 4.6mm, 2.6μm particle size) as stationary phase with a mobile phase consisting of buffer (0.01M Ammonium acetate pH adjusted to 5.0 with diluted acetic acid) and the methanol in the ratio of 40:60 v/v at a flow rate of 1.0ml/min and the detection wavelength was 273nm. The method was statistically validated for linearity, accuracy (recovery), precision, specificity, robustness, and forced degradation study. The method was successfully applied for analysis of a tablet formulation.