Development and Validation of New RP-UPLC Method for the Quantitative Analysis of Mycophenolate in Tablet Dosage Form.

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 C18 (4.6x100mm, 3.5μm, Make XBridge) column using an isocratic method with mobile phase composed of Potassium di-hydrogen phosphate Acetonitrile in the ratio 3565 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 10-50μg/ml and the linear regression obtained was > 0.999. Precision, evaluated by intra- and inter-day assays had relative standard deviation (R.S.D) values within 1.5%. Recovery data were in the range 99.1-102.0% with R.S.D. values < 1.5%. Conclusion: The method is precise, accurate, linear, robust and fast. The short retention time of 0.613 min allows the analysis of a large number of samples in a short period of time and, therefore, should be cost-effective for routine analysis in the pharmaceutical industry.