Development and validation of HPTLC method for the determination of mycophenolate mofetil in bulk and pharmaceutical formulation.

AIM: Described in this manuscript is the first ever reported, new, simple, high-performance thin-layer chromatographic method for the determination of mycophenolate mofetil in bulk and tablet dosage form. MATERIALS AND METHODS: The drug was separated on aluminum plates precoated with silica gel 60 F254 with toluene, acetone, and methanol in the ratio of 6:2:2 (v/v/v) as the mobile phase. Quantitative analysis was performed by densitometric scanning at 254 nm. RESULTS: The method was validated for linearity, accuracy, precision, and robustness. The calibration plot was linear in the range of 100-500 ng band(-1) for mycophenolate mofetil. The method was successfully applied to the analysis of the drug in a pharmaceutical dosage form.