Development and Validation of Analytical Method for Simultaneous Estimation of Citicoline Sodium and Preservative Methyl Paraben in Liquid Oral Formulation by RP-HPLC
A rapid, accurate, specific, linear and sensitive reverse-phase HPLC method has been developed and validated for simultaneous determination of citicoline (CITI) and preservative methyl paraben (MetP) in oral drop formulation. Chromatographic separation was carried out on (Merck) C8 column (250mm x 4.6mm, 5μm particle size) using a mobile phase consisiting of 0.1 M monobasic potassium phosphate: Methanol (70: 30, v/v). Flow rate was maintained at 1.5 ml/min and 30ºC column temperature with the detection wavelength at 294 nm. The calibration curve was found to be linear over the range of 80-120 ppm for citicoline sodium and 8-12 ppm for methyl paraben with a square correlation coefficient of 0.999 and 0.999 for CITI and MetP respectively. Citicoline sodium and methyl paraben were resolved on the stationary phase and the retention times were found to be 2.06 and 14.68 minutes for citicoline sodium and methyl paraben respectively. The percentage purity of Citicoline sodium and methyl paraben was found to be >99.0%. The method was found to be simple, accurate, precise, and reproducible which were within the acceptance limit according to ICH guidelines and easy to apply, making it very suitable for routine analysis of citicoline sodium and methyl paraben in oral drop formulation.