Abstract
A new and accurate chiral liquid chromatographic method was described for the enantiomeric separation of ZTR-5 [(4 S)-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 × 4.6 mm, 5 μm) 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 (4 R)-4-(4-aminobenzyl)-2-oxazolidinone [( R)-isomer] were found to be 250 and 750 ng/ml, respectively, for 10 μl 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.
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