Citicoline sodium subjected to different ICH prescribed stress conditions. Degradation was found to occur in hydrolytic, oxidative, thermal condition, while the drug was stable to photolytic and humidic condition. A stability indicating high performance liquid chromatography (HPLC) method was developed for analysis of drug in the presence of degradation products. The chromatographic method was fine tuned using the sample generated from forced degradation studies. Good resolution between the peaks corresponds to degradation products and the analyte was achieved on 5 , 250 mm × 4.6 mm i.d., C18 column (Phenomenox, USA). Mobile phase consists of mixture of water: orthophosphoric acid (99:1, v/v) (pH 4.0). Quantitation was achieved with UV detection at 272 nm based on peak area. The method was validated for accuracy, precision, linearity, range and selectivity.
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