Abstract :
A simple and sensitive stability-indicating reverse phase high-performance liquid chromatographic (HPLC)
method was developed and validated for determination of Mycophenolate mofetil in tablet dosage forms.
Mycophenolate mofetil is an immunosuppressant drug used extensively in transplant medicine. The chromatographic
separation (isocratic mode) was performed on Shimadzu Model LC-Class-Vp with Lichrocart / Lichrosphere 100
(250 × 4.6 mm, 5 µm particle size) using C-18 column and mobile phase (52: 48, v/v) containing tetra butyl
ammonium hydrogen sulphate and methanol with flow rate 1.2 mL/min. Ultraviolet detection was carried out at 216
nm. Lamotrigine has been used as internal standard. Mycophenolate mofetil has shown linearity over the
concentration range 0.5–160 μg/mL (r2 = 0.999) and the method was validated. The limit of quantitation and limit of
detection 0.321 and 0.102 µg/mL respectively. Forced degradation studies were performed and Mycophenolate
mofetil is found to be more sensitive towards alkaline conditions.
Keyword :
Mycophenolate mofetil, RP-HPLC, stability-indicating, Lamotrigine, validation.