Development and Validation of Dissolution Method for Citicoline Controlled Release Tablets by Reverse Phase High Performance Liquid Chromatographic Method

A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method has been developed for determination (drug release) of Citicoline in controlled release tablet dosage form by reverse phase separation was carried out on a columns containing different stationary phases, the final choice giving satisfactory theoretical plates and tailing with good reproducibility and run time, with dimension 250 mm × 4.6 mm internal diameter, 5-μm particle; Zorbax C18 reversed-phase column. The mobile phase consisting of buffer: methanol (95:5, pH 6.0) at a flow rate of 0.8mL/min. The UV detection wavelength was set at 270nm. The retention time for Citicoline was found to be 6.4 min. and recoveries from controlled release tablet dosage form were between 99.7% and 104.4%. The method was validated for specificity, linearity, accuracy, precision and robustness. The proposed method was optimized and validated as per the ICH guidelines. Key words: Citicoline monosodium, Reverse Phase -High performance liquid chromatography, Dissolution, Validation.