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- W3123099360 abstract "Impurity profiling of active pharmaceutical ingredients is a crucial step in assessing their quality. Moreover, the chemical nature of nimodipine makes it susceptible easily to acidic and alkaline hydrolysis. On the other hand, nimodipine is co-formulated with citicoline sodium pharmaceutically as tablets to treat cerebral ischemia. In this study, three degradation products of nimodipine were synthesized, isolated and characterized with aid of FTIR spectroscopy, 1H-NMR as well as LC-MS/MS after exposing to drastic acidic and alkaline conditions. Subsequently, a simple, selective and valid RP-HPLC method was developed for simultaneous estimation of nimodipine and citicoline in the presence of nimodipine acid and alkaline degradation products in bulk and tablets. Chromatographic separation was achieved using an isocratic mobile phase consisting of acetonitrile: 0.02 M KH2PO4 (containing 0.2% v/v, triethylamine and adjusted to pH 3.0 with orthophosphoric acid) (70:30, v/v) at a flow rate 1.0 mL min-1 at ambient temperature (25 ºC) on a Eurospher II C18 (250 mm × 4.6 mm, 5 µm) column with UV detection at 270 nm for citicoline and 235 nm for nimodipine and its acidic and alkaline hydrolytic products. Linearity, accuracy and precision were found to be acceptable over a concentration range of (4.5–120 μg mL-1) for nimodipine and (15–400 μg mL-1) for citicoline. The proposed method could be successfully applied for the routine analysis of the studied drugs in their pharmaceutical preparation in the presence of nimodipine common degradation products without any preliminary separation step." @default.
- W3123099360 created "2021-02-01" @default.
- W3123099360 creator A5079416120 @default.
- W3123099360 date "2021-01-19" @default.
- W3123099360 modified "2023-09-26" @default.
- W3123099360 title "Synthesis, Isolation and Characterization of three acid and alkaline hydrolytic products of Nimodipine and Development of a valid RP-HPLC method for simultaneous determination of Nimodipine and Citicoline sodium in the presence of Nimodipine degradation products in Bulk and Tablets" @default.
- W3123099360 doi "https://doi.org/10.30744/brjac.2179-3425.ar-52-2020" @default.
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