Stability indicating assay of citicoline monosodium (API) and their degradation products by HPLC

A Simple, selective, rapid, precise and economical RP-HPLC stability - indicating method has been developed and validated for the Quantitative Estimation of Citicoline monosodium (API) and their degradation products. Chromatographic separation was accomplished using C18 column with mobile phase consisting of: Tbahs Buffer: Methanol (95:05): Methanol (95:05, v/v), flow rate was 1.0 ml/min. and the detection wavelength was 270nm.The method was validated for linearity, accuracy, precision, specificity, Robustness. The API was subjected to stress condition of Acid Decomposition (1.0 N HCl refluxed for 12 hrs at 800C) Alkali Decomposition (1.0 N NaOH refluxed for 12 hrs at 800C), Neutral hydrolysis (Dist. Water refluxed for 5 days at 800C) Oxidative decomposition (30% H2O2 for 24 hrs at RT), Thermal decomposition (Drug at 1000C for 24hrs) Photolytic Decomposition (70,000-80,000 lux at 7 days) Percentage assay of degraded products were Acid (20.42, 11.26), Alkali (20.93,8.22), Neutral hydrolysis (22.42), Oxidative decomposition (23.65) respectively and there is no degradation in Thermal and Photolytic Decomposition was found in Degradation studies. Forced degradation study shows that Citicoline monosodium is a labile in acid, alkali, Neutral and oxidative conditions. It is stable to light and dry heat. No interference of degradation product was found at the RT of principle peak. The assay recommended for analysis of the API and degradation products in stability samples. It may be applied to a routine analysis in industries.

Author(s): Shailendra Bindaiya and Ameeta Argal

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