*Corresponding author:Pritam S Jain, RC Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur, Dist Dhule 425 405 (MS)
Received: October 13, 2017; Published: October 24, 2017
To view the Full Article Peer-reviewed Article PDF
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.
Keywords : Rizatriptan Benzoate; Rp-Hplc, Validation, Purity Evaluation; Degradation Product