Development and Validation of Environmental Conscious High Performance Liquid Chromatography Method for Determination for Ranitidine Hydrochloride in Solid Dosage Form

A simple, specific and accurate reverse phase liquid chromatographic method has been developed for the estimation of Ranitidine HCl from tablet formulation. The drug is official with Indian Pharmacopeia, United States Pharmacopeia British Pharmacopoeia, however these Compendial procedures does not involve aqueous solvent as diluents. The separation was carried out using 25 cm x 4.0 mm packed with octadecylsilane bonded to porous silica (10 mu m) column and the mobile phase consisted of (methanol: ammonium Acetate-85:15) in isocratic mode. The flow rate was 1.00 ml/min and effluent was monitored at 322 nm. The new method for the assay of Ranitidine hydrochloride tablet was validated as per ICH guidelines for Linearity, accuracy, precision, Robustness, and Specificity. The described is linear (Correlation coefficient is 0.999). The method is found to be accurate between concentrations 80 % to 120 % of target concentration (112 mu g/mL) of Ranitidine. The precision, ruggedness and robustness values were also within the prescribed limits (<1% for system precision and <2% for other parameters). The method was found reproducible as per the predefined criteria. The method was successfully used for quantitative determination of Ranitidine HCl from tablet dosage form.