Abstract

A simple and practical reversed‐phase liquid chromatographic (RP‐LC) method is described for the determination of L‐enantiomer in the bulk drug substance of nateglinide. Enantioseparation was achieved at ambient temperature on a Chiralcel OD‐R column (250 × 4.6 mm, 10 µm) using a mobile phase consisting of 0.6 mol/L sodium perchlorate and acetonitrile (48:52, v/v, pH 2.0) delivered at a flow rate of 0.2 mL/min. Analytes were monitored at 220 nm. The method is selective and sensitive for this purpose with a limit of detection (LOD) and quantitation (LOQ) of 0.3 µg/mL and 0.8 µg/mL for the L‐enantiomer, and 0.4 µg/mL and 1.0 µg/mL for the D‐enantiomer, respectively.

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