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A highly stereo-specific liquid chromatographic method was developed and validated for the quantification of enantiomeric impurity (R-enantiomer) in novel oxazolidinone antibacterial agent (WCK 4086), a drug substance. The separation was achieved on Chiralpak AD-H (amylose-based chiral stationary phase) using a mobile phase consisting of n-hexane:2-propanol:methanol:trifluoroacetic acid (80:10:10:0.4, v/v/v/v) at a flow rate of 1.0 mL min-1. Chromatographic resolution between two enantiomers was found to be more than 2.0. Method was extensively validated for the quantification of R-enantiomer in WCK 4086 and proved to be robust. Method was found to be highly specific as all other related impurities were separated from the enantiomers. The calibration curve for R-enantiomer showed an excellent linearity over the concentration range of 1-5 μg mL-1. Limit of quantitation (LOQ) and limit of detection (LOD) for R-enantiomer were 0.009 μg and 0.003 μg, respectively. Average recovery of the R-enantiomer was in the range of 94.55-109.67%. Analytical solutions were found to be stable up to 70 h at room temperature. Developed method was found to be specific, sensitive, precise and accurate for quantitative determination of R-enantiomer in WCK 4086 and useful for controlling the enantiomeric impurity in drug substance used for preclinical studies.

journal of chromatographic science

Development and Validation of the Chiral Liquid Chromatography Method for Separation of Enantiomeric Impurity in Novel Oxazolidinone Antibacterial Agent WCK 4086