New enantioselective liquid chromatography method development and validation of dipeptidyl peptidase IV inhibitors using a macrocyclic glycopeptide (vancomycin) chiral stationary phase under polar ionic mode condition (original) (raw)

Chirality

Abstract

The direct separation of dipeptidyl peptidase IV (DPP‐4) inhibitors such as Sitagliptin (STG), Linagliptin (LIG), and Saxagliptin (SAG) enantiomers in normal phase conditions have been achieved on immobilized polysaccharide‐based chiral stationary phases (CSPs), as well as on the macrocyclic glycopeptide vancomycin chiral stationary phase (Chirobiotic V2) under polar ionic mode. The enantiomers of these targets could be separated completely (resolution factor Rs > 2) using the Chirobiotic V2 column in polar ionic mode with the mobile phase (MeOH/AcOH/TEA 100/0.3/0.1 v/v/v) in an isocratic elution at 1.0 ml min−1. The effect of the mobile phase composition on separation, including buffer salts, acid–base modifiers, and analyte structures, was evaluated. The developed technique was validated in the polar ionic mode according to the International Conference on Harmonization (ICH) Q2R1 guidelines in terms of accuracy, precision, selectivity, linearity, limit of detection (LOD), and l...

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