A simple, selective, linear, specific, precise and accurate High Performance Liquid Chromatography (HPLC) method was developed and validated for rapid assay of Loperamide Hydrochloride in finished product.Isocratic elution at a flow rate of 1.5 ml/min was employed on an Inertsil-ODS 3V, C18, 100×4.6 mm, 5µ column.The UV detection wavelength was 224 nm.The mobile phase consisted of acetonitrile: buffer: 1M NaOH = 390: 610: 0.5.The method was validated in terms of linearity, specificity, accuracy, precision and robustness study.The method was validated as per the International Conference on Harmonization (ICH) guidelines.The method was successfully applied to the analysis of pharmaceutical formulation containing Loperamide Hydrochloride with excellent recovery.
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