A validated chiral LC method for the enantiomeric separation of Zolmitriptan key intermediate, ZTR-5

Abstract

A new and accurate chiral liquid chromatographic method was described for the enantiomeric separation of ZTR-5 [(4S)-4-(4-aminobenzyl)-2-oxazolidinone, (S)-isomer], a key intermediate of Zolmitriptan in bulk drugs. The enantiomers of ZTR-5 were baseline resolved on a Chiralpak AD-H (250 mm x 4.6 mm, 5 microm) column using a mobile phase system containing hexane:ethanol (70:30, v/v). The resolution between the enantiomers was not less than four and interestingly distomer was eluted prior to eutomer. The limit of detection and limit of quantification of (4R)-4-(4-aminobenzyl)-2-oxazolidinone [(R)-isomer] were found to be 250 and 750 ng/ml, respectively, for 10 microl injection volume. The percentage recovery of (R)-isomer ranged from 92.0 to 105.6 in the bulk drug samples of ZTR-5. The validated method yielded good results regarding precision, linearity, accuracy and ruggedness. The proposed method was found to be suitable and accurate for the quantitative determination of (R)-isomer in bulk drug samples of ZTR-5.