Force Degradation Study of Rizatriptan Benzoate by Rp- HPLC Method and Characterization of Degraded Product by Pritam S Jain in BJSTR
Abstract
The objective of the work was to study the degradation behavior of
rizatriptan benzoate under different ICH recommended stress
conditions by HPLC, and to establish a validated stability indicating LC
assay method. Rizatriptan benzoate was subjected to stress conditions
of hydrolysis and oxidation decomposition. Extensive degradation was
found to occur in acidic medium. Mild degradation was observed in
alkaline and oxidative conditions. Rizatriptan benzoate was stable to
photolytic and thermal stress conditions. Successful separation of drug
from degradation products formed under stress conditions was achieved on
a Perfectsil (C18, 250 mm × 4.6 mm, 5.0 μ) and 0.01 M Phosphate
buffer : methanol (80:20 v/v) as the mobile phase at a flow rate of 1.0
mL /min at ambient temperature and detected at 225 nm. pH of buffer
is adjusted 5.0 with 85 % of otho phosphoric acid. Characterization of
the degradent product was separately. The molecular weight of impurity
product was found to be 188.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.