Analytical method validation of ranolazine tablets by RP-HPLC Mahatara Ratan Bahadur1, Maharjan Sajan2,*, Thapa Roshni1, Budhathoki Uttam1 1Department of Pharmacy, School of Science, Kathmandu University, Dhulikhel, Nepal 2Department of Pharmacy, CiST College, New Baneshwor, Kathmandu, Nepal *Corresponding Author E-mail: maharjansajan02@gmail.com
Online published on 23 May, 2025. Abstract 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. Top Keywords Ranolazine, Eco-friendly method, RP-HPLC, Analytical method validation. Top |