INTRODUCTION Mycophenolate mofetil (MMF) is an immunosuppressant and prodrug of mycophenolic acid, used extensively in trans- plant medicine. It is a reversible inhibitor of inosine mono- phosphate dehydrogenase 1 (IMPDH) in purine biosynthesis, more specifically guanine synthesis, which is necessary for the growth of T cells and B cells. Mycophenolate mofetil is also used in the treatment of autoimmune diseases, such as Behcet's disease, pemphigus vulgaris and systemic lupus erythematosus. The chemical name for mycophenolate mofetil is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6- methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4- hexenoate. Its empirical formula is C 23 H 31 NO 7 with molecular weight 433.50 and soluble in acidic medium. It is available in the brand names such as CellCept, Myfortic. One UV-spectrophotometric method is reported 2 to estimate mycophenolate mofetil in bulk and pharmaceutical formulations at 250 nm in 0.1 N hydrochloric acid (pH 1.2) using acetate buffer (pH 4.5). A high-performance liquid- chromatography method 3 is developed and validated for the estimation of mycophenolate mofetil in tablets, capsules and nanoparticles by using photo diode array detector. A simulta- neous determination of mycophenolic acid and valproic acid in human plasma by HPLC 4 is reported based on derivatization by high-performance liquid chromatography with fluorescence Validated RP-HPLC Method for the Determination of Mycophenolate Mofetil in Tablet Dosage Forms T. VIJAYA BHASKARA REDDY, G. RAMU, M. SRAVAN KUMAR and C. RAMBABU * Department of Chemistry, Acharya Nagarjuna University, Nagarjuananagar-522 510, India *Corresponding author: E-mail: rbchintala@gmail.com (Received: 24 May 2012; Accepted: 6 March 2013) AJC-13072 A precise, accurate and more sensitive RP-HPLC method is developed to estimate the amount of mycophenolate mofetil in pure and tablets using Waters-Alliance HPLC system equipped with auto sampler and ultra-violet detector. The method is carried out on a Symmetry C18 (4.6 mm ID × 150 mm, 5 μm, Make: XTerra) with a mobile phase consisting of acetonitrile and potassium dihydrogen phosphate buffer of pH = 4.0 in the ratio 65:35 volume/volume at a flow rate of 0.7 mL/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 2.647 min. The developed method is 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, 0.052 and 0.171 μg mL -1 , respectively. The developed method is found to be simple, fast and economic and hence it can be used as an alternative method in quality control. Key Words: RP-HPLC, Mycophenolate mofetil, Retention time, Linearity, Quality control. detection. A few LC-MS/MS 5-10 methods have been reported for the determination of mycophenolate mofetil present in biological fluids in humans. A few HPLC 11-14 are also reported in the literature to determine the amount of the drug mostly in biological matrixes. Most of the reported methods are concentrated on the biological fluids. From the extensive surrey of the literature it is found that a very few methods are present to determine the drug in formulations. Therefore the author has attempted to develop a more sensitive HPLC method for the assay of the chosen drug in pharmaceutical formulations. The LOD and LOQ values of the reported method are very much lower than that of that of the reported method3. More over the linearity limits for the proposed method are 10-50 μg mL -1 which is lower than the existing method of 120-800 μg mL -1 indicating that the method is more sensitive. The UV absorption spectrum (Fig. 1) of the drug gives three peaks at 216, 250 and 304 nm. It is found that the absorbance at 216 nm is nearly five times more than the one at 250 nm. Hence the all spectral measurements are made at 216 nm to achieve better sensitivity. EXPERIMENTAL The separation is carried out on Waters-Alliance HPLC system equipped with auto sampler, binary gradient pump, dual wavelength UV-visible detector and symmetry C18 (4.6 Asian Journal of Chemistry; Vol. 25, No. 9 (2013), 4788-4790 http://dx.doi.org/10.14233/ajchem.2013.14105