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

A.Nageswari, P.Surya Prakash Rao, B.Gowri Sankar Rao, B.Satyanarayana, CH. Sridhar, V.Ranga Reddy, Mukkanti

A rapid isocratic chiral LCmethod has been developed for the separation of (2R,3R,5R)-2-Amino-3-hydroxy-5-(tert-butyl oxy carbonyl) amino-1,6-diphenyl hemi succinic acid (R-BOCamine) from(2S,3S,5S)-2-Amino-3-hydroxy- 5-(tert-butyl oxy carbonyl) amino-1,6-diphenyl hemi succinic acid (S-BOC amine). 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, trifluoroacetic acid and triethyl amine (950:50:1:1,v/v) as themobile phase at ambient temperature. Flowrate was kept at 1.0 mLmin-1 and elution wasmonitored by UV detection at 210 nm. This method allowed for the detection and quantification of R-BOC amine of levels at 0.15 and 0.5 µg mL-1 respectively. Themethod was validated by following ICH guidelines.