Chiral Separation of Citalopram by Reversed Phase Hplc Using Sulfated Beta Cyclodextrin as Chiral Mobile Phase Additive

Objective: To develop a simple and cost effective chiral HPLC method for the separation of citalopram (CIT) enantiomers using chiral mobile phase additives (CMPAs). Methods: Sulfated beta cyclodextrin (S-β-CD) was synthesized in our laboratory and was evaluated as a CMPA. The parameters affecting the resolution were optimized. CIT enantiomers were resolved on an achiral Kromasil C8 column (150 mm × 4.6 mm, 5 μm) using methanol and 20 mM KH2PO4 Results: Synthesized S-β-CD gave a better resolution than the marketed form. This method was validated as per ICH guidelines and was found to comply with the standard norms. A good linearity was observed in the concentration range of 1-30 μg/ml with R (pH 3) containing 12 mM S-β-CD (35:65) as the mobile phase with a flow rate of 1 ml/min at 240 nm. Chiral resolution capacity of synthesized S-β-CD was compared to the marketed product. The method using synthesized S-β-CD as CMPA was validated and applied for the quantitative determination of CIT enantiomers in bulk drug and tablet formulation.