AbstractThe present work is aimed at development and validation of RP HPLC method which issimple, specific, precise, and accurate for estimation of Mycophenolate Mofetil and itsprocess-related impurity in bulk and pharmaceutical dosage forms. Extensive literaturesurvey revealed no method for estimation of the above said. The characterization ofsynthesized impurities detected by using FTIR, NMR and MS. The RP-HPLC method wasdeveloped according to ICH Q2B guidelines for quantitation of impurity in bulk andformulations. The method was validated as per ICH guidelines. The method was found to belinear, precise, accurate, robustand rugged. The present study focuses on the various steps,parameters involved in HPLC condition. Various applications of this system also discussed.HPLC process development is important in case of drug discovery, drug development andpharmaceutical products. It can be adopted apparently for routine quality control study ofresearch and formulation tests. The method is carried out on a Symmetry C18 (4.6 mm ID ×150 mm, 5 µm, Make: X-Terra) with a mobile phase consisting of aceton itrileand potassiumdi-hydrogen phosphate buffer of pH=4.0 in the ratio 65:35 volume/ volume at a flow rate of0.7mL/min. The detection of eluted components is carried out at a wavelength of 216 nm.The retention time of mycophenolate mofetil is found to be 2.647min.The developed methodis validated in terms of accuracy, precision, linearity, limit of detection, limit of quantization.The linearity limits, LOD and LOQ of the developed method are found to be 10-50, 0.052and 0.171 µg mL-1 , respectively. The developed method is found to be simple, fast andeconomic and hence it can be used as an alternative method in quality control.

AbstractThe present work is aimed at development and validation of RP HPLC method which issimple, specific, precise, and accurate for estimation of Mycophenolate Mofetil and itsprocess-related impurity in bulk and pharmaceutical dosage forms. Extensive literaturesurvey revealed no method for estimation of the above said. The characterization ofsynthesized impurities detected by using FTIR, NMR and MS. The RP-HPLC method wasdeveloped according to ICH Q2B guidelines for quantitation of impurity in bulk andformulations. The method was validated as per ICH guidelines. The method was found to belinear, precise, accurate, robustand rugged. The present study focuses on the various steps,parameters involved in HPLC condition. Various applications of this system also discussed.HPLC process development is important in case of drug discovery, drug development andpharmaceutical products. It can be adopted apparently for routine quality control study ofresearch and formulation tests. The method is carried out on a Symmetry C18 (4.6 mm ID ×150 mm, 5 µm, Make: X-Terra) with a mobile phase consisting of aceton itrileand potassiumdi-hydrogen phosphate buffer of pH=4.0 in the ratio 65:35 volume/ volume at a flow rate of0.7mL/min. The detection of eluted components is carried out at a wavelength of 216 nm.The retention time of mycophenolate mofetil is found to be 2.647min.The developed methodis validated in terms of accuracy, precision, linearity, limit of detection, limit of quantization.The linearity limits, LOD and LOQ of the developed method are found to be 10-50, 0.052and 0.171 µg mL-1 , respectively. The developed method is found to be simple, fast andeconomic and hence it can be used as an alternative method in quality control.