REVIEW ON METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CITICOLINE AND METHYL COBALAMIN IN PHARMACEUTICAL DOSAGE FORM
Garamsandh Gandhi V.*, Dr. Kamalakannan Dhanabalan, Dr. Manivannan R., Gokul M., Pragatheswaran S., Sangeetha V. S. and Surendar K.
ABSTRACT
This study presents the development and validation of a simple, accurate, precise, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of citicoline and methyl cobalamin in pharmaceutical dosage forms. Unlike previous studies, which did not explore UV-Visible spectroscopy methods, chromatographic separation was achieved using an HPLC system (Waters with Empower2 software) with a C18 (YMC, 250 x 4.6 mm, 5 µm) column. The mobile phase consisted of a 50:50 v/v mixture of potassium dihydrogen phosphate and acetonitrile, adjusted to pH 3.0 with ortho phosphoric acid. The method operated at a flow rate of 0.8 mL/min, with the column maintained at ambient temperature, and detection occurred at 295 nm using a PDA detector. Citicoline and methyl cobalamin were effectively resolved with retention times of 3.2 and 4.1 minutes, respectively. The method demonstrated linearity within the concentration range of 500-1500 μg/mL for citicoline and 0.75-2.25 μg/mL for methyl cobalamin, with a correlation coefficient (r²) of 0.999. The method was validated for precision, accuracy, specificity, ruggedness, robustness, and stability under forced degradation conditions, confirming its suitability for routine pharmaceutical analysis.
Keywords: Citicoline, Methyl cobalamin, HPLC, UV, RP-HPLC.
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