Force Degradation Study of Rizatriptan Benzoate by Rp- HPLC Method and Characterization of Degraded Product
Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2017, Vol 1, Issue 5
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. Rizatriptan benzoate (Figure 1) is a triptan drug used for the treatment of migraine headaches. It is a selective 5-Hydroxytryptamine 1 receptor subtype agonist [1]. Since there are only few methods are available for the determination of Rizatriptan benzoate. The present work is an attempt to estimate the same by a new force degradation method. The literature review shows very few methods for the determination of Rizatriptan benzoate and pharmaceutical validations by HPLC method but that various other methods like UV spectroscopic method for Rizatriptan benzoate [2,3], HPLC method for Rizatriptan benzoate [4], LC-MS/MS method for determination of Rizatriptan benzoate in human plasma [4]. This method can be successfully used for routine analysis of Rizatriptan benzoate as it is rapid, simple, selective and sensitive method for the determination using High Performance Liquid Chromatographic (HPLC) technique [5].
Authors and Affiliations
Pritam S Jain, Harshal P Chaudhari, Gayatri B Patil, Sanjay J Surana
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