____________________________________________________________________________________________ *Corresponding author: Email: abhilashmpharm@gmail.com; British Journal of Pharmaceutical Research 3(3): 363-373, 2013 SCIENCEDOMAIN international www.sciencedomain.org Development and Validation of New RP-UPLC Method for the Quantitative Analysis of Mycophenolate in Tablet Dosage Form P. Raja Abhilash 1* , K. Vasanth Kumar 2 and V. Sateesh Kumar 2 1 Department of Pharmaceutical Analysis and Quality Assurance, S.V.S. School of Pharmacy, Bheemaram, Hanamkonda, India. 2 Department of Pharmaceutics, Jangaon Institute of Pharmaceutical Sciences, Jangaon, India. Authors’ contributions This work was carried out in collaboration between all authors. Author PRA designed the method, wrote the first draft of manuscript and evaluated validation parameters. Author KVK has reviewed the various literatures. Author PRA has prepared the necessary sample and standard solutions. Author VSK has performed the statistical analysis and managed the analyses of the study. All authors read and approved the final manuscript. Received 6 th October 2012 Accepted 23 rd January 2013 Published 12 th April 2013 ABSTRACT Aim: To develop and validate a novel and rapid reverse phase ultra-performance liquid chromatographic (RP-UPLC) method for the estimation of mycophenolate in tablet formulations. Place and Duration of Study: Department of pharmaceutical analysis, S. R. College of Pharmacy ananthasagar, between February 2012 and June 2012. Methodology: Chromatographic separation was achieved on a Symmetry C 18 (4.6x100mm, 3.5μm, Make: XBridge) column using an isocratic method with mobile phase composed of Potassium di-hydrogen phosphate: Acetonitrile in the ratio 35:65 v/v). The flow rate was 0.2 ml/min, temperature of the column was maintained at ambient and detection was made at 228 nm. The run time was as short as 1.2 min. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. Results: The developed method was linear for mycophenolate from 10-50g/ml and the linear regression obtained was > 0.999. Precision, evaluated by intra- and inter-day Research Article