s
i
ANANBIOANAL - 2010
Pharmaceutical R & D Summit
Development and Validation of Stability Indicating Lc- Pda
Method for Mycophenolate Mofetil (Mmf) in Presence of its
Impurities and Major Degradation Product Mycophenolic Acid
Department of Pharmaceutical Chemistry, Y.B. Chavan College of Pharmacy, Aurangabad, India
F
actorial design tool was applied for development of isocratic reversed-phase
stability indicating HPLC method for the analysis of Mycophenolate mofetil
(MMF), its degradation products Mycophenolic acid (MPA) and degradation products
(DP3). Separation was achieved on a Symmetry C18 (250 mm × 4.6 mm, 5.0 µ)
column using a Methanol: acetate buffer (75:25 v/v), pH 6.0 (adjusted with acetic
acid), at 0.5 ml flow rate, column maintained at 55 0
C and data was integrated at
251 nm. MMF was subjected to hydrolysis, oxidation, heat degradation, etc. under
all these conditions degraded products were well separated. The method validation
characteristics included accuracy, precision, linearity, range, specificity, LOD and
LOQ. Robustness testing was conducted to evaluate the effect of minor changes
to the chromatographic conditions and to establish appropriate system suitability
parameters. The proposed method was used to investigate kinetics of acid, alkali
hydrolysis and oxidation process. Major degradation product MPA and DP3 were
isolated and quantitated. Characterization of MPA by NMR and LC-MS/MS and
other degraded products by LC-MS/MS was attempted successfully. The method
was used successfully for the quality assessment of three MMF drug products
and its acid, alkali and oxidative degradation kinetics study. A simple and efficient
stability indicating reverse-phase HPLC method was developed and was found to
be accurate, precise and linear across the analytical range and is reported for the
first time. The method is simple, fast, sensitive and specific for the determination
and quantification of MMF, MPA and DP3.
doi:10.4172/2155-9872.1000007
(Mpa) Using Factorial Design Tool and Use of Mass Spectroscopy
Anna Pratima Nikalje
ANALBIOANAL-2010
O
M
I
C
S
P
i
u
h
b
l
n
g
G
r
o
u
p