Abstrakt

A validated chiral LC method for enantiomeric separation of levocetrizine using protein based chiral stationary phase

Ch.Dharma Raju, K.Sudhakar Babu, P.Shanthi, P.Lalitha, J.S.Srinivas

A rapid isocratic chiral LCmethod has been developed for the separation of (S)-Cetirizine (Dextrocetirizine) and (R)-(-)-Cetirizine (Levocetirizine).Good resolution with RS > 1.5 was obtained using protein based chiral stationary phase, ES-OVMcolumn (150 x 4.6mm, 5µm particle size) and 20mM potassium dihydrogen orthophosphate (pH 7.0) buffer, Acetonitrile (87:13,v/v) as the mobile phase at ambient temperature. Flow rate was kept at 0.6 mL min-1 and elution was monitored by UV detection at 230 nm. This method allowed for the detection and quantification of R-Cetrizine levels at 0.056 and 0.182 µg mL-1 respectively.Themethodwas validated by following ICH guidelines.