Cost Effective, Efficient and Stability indicating analytical method validation for Ranolazine related by Reverse Phase High Performance Liquid Chromatography in drug substances
A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Ranolazine in drug substances. Isocratic elution at a flow rate of 1.4ml/min was employed on Hypersil BDS C18, 150 x 4.6 mm, 5µm or Equivalent at 40°C column temperature. The mobile phase consisted of Mobile phase-A: Mobile phase-B (55:45) (Disodium hydrogen orthophosphate buffer with pH 7.0 and Acetonitrile). The UV detection wavelength was at 205 nm. Linearity was observed in concentration range of 0.07-0.82 ppm for ranolazine impurity-I and concentration range of 0.07-0.78 ppm for ranolazine impurity-II. The retention time for Ranolazine was 7.6 min. The method was validated for validation parameter like specificity, force degradation, linearity, accuracy, precision and robustness as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Ranolazine in pharmaceutical dosage forms.
Keywords: Ranolazine, Method Validation, Drug Substances, HPLC
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