ANALYTICAL RP-HPLC METHOD FOR DEVELOPMENT AND VALIDATION OF CITICOLINE SODIUM AND METHYLCOBALAMIN IN COMBINED TABLET FORMULATION

SHWEA D. SINGH; FALGUN A; DIMAL A SHAH; USMANGANI K CHHALOTIYA

Authors

SHWEA D. SINGH Department of Pharmaceutical Analysis, Indukaka Ipcowala College of Pharmacy, New Vallabh Vidayanagr, Anand, Gujarat, India.
FALGUN A Department of Pharmaceutical Analysis, Indukaka Ipcowala College of Pharmacy, New Vallabh Vidayanagr, Anand, Gujarat, India.
DIMAL A SHAH Department of Pharmaceutical Analysis, Indukaka Ipcowala College of Pharmacy, New Vallabh Vidayanagr, Anand, Gujarat, India.
USMANGANI K CHHALOTIYA Department of Pharmaceutical Analysis, Indukaka Ipcowala College of Pharmacy, New Vallabh Vidayanagr, Anand, Gujarat, India.

Keywords:

Citicoline (CITI), Methylcobalamin(MCA), RP-HPLC, Method Development, Validation

Abstract

Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method have been developed and validated for the
estimation of Citicoline Sodium and Methylcobalaminin Bulk drug and Pharmaceutical dosage form. The developed
method is rapid, accurate, precise, simple and economical than the previous methods. The separation was carried out
usingPhenomenex Luna , C18, column having 250mm X 4.6mm, 5?m particle size, in isocratic mode, with mobile phase containing Acetonitrile: 0.02M KH2PO4 [60: 40, v/v]. The flow rate is 1 ml / min and effluents are monitored at 554 nm. Chromatogram showed peak at a retention time of 3.8 min for Citicoline sodium and 2.3 min for Methylcobalamin . The method is validated for system suitability, linearity, precision, accuracy specificity, ruggedness, robustness, LOD and LOQ. Recovery of Citicoline Sodium and Methylcobalamin is found to be in the range of 99.76 - 101.79 % and 110.92% and 111.79%, respectively. The LOD and LOQ for estimation of Citicoline Sodium and Methylcobalamin are found to be 0.003 ?g / ml, 0.0.01 ?g / ml, and 0.01?g / ml, 0.05 ?g / ml respectively. Proposed method can be successfully applied for the quantitative determination of Citicoline Sodiumand Methylcobalamin in Bulk drug and Pharmaceutical dosage form.