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A validated chiral LC method for enantiomeric separation of intermediate of lopinavir by using cellulose based chiral stationary phase

Surya Prakash Rao, A.Nageswari, V.Ranga Reddy, Mukkanti

A rapid isocratic chiral LCmethod has been developed for the separation of 2R-(1-Tetrahydro pyrimid-2-onyl)-3-methyl butanoic acid (R-THPA) from 2S-(1-Tetrahydro pyrimid-2-onyl)-3-methyl butanoic acid. (S-THPA).Good resolution with RS > 3 was obtained using cellulose based chiral stationary phase, chiralcelOD-H column (250 x 4.6mm, 5µm particle size) and n-hexane, ethanol and trifluoroacetic acid (900:100:2, v/v) as the mobile phase at ambient temperature. Flow rate was kept at 1.2 mL min-1 and elution was monitored by UV detection at 210 nm. This method allowed for the detection and quantification of R-THPA of levels at 0.5 and 1.5µg mL-1 respectively. The method was validated following ICH guidelines.