A Sensitive Direct Chiral Liquid Chromatography Tandem Mass Spectrometry Method for the Enantio—selective Analysis of Imeglimin in Formulation

The purpose of this study was to separate and develop a sensitive chiral liquid chromatography tandem mass spectrometry (LC-MS/MS) technique to estimate the (+) and (-) enantiomers of imeglimin in its formulation and validate individual enantiomer of the drug.Imeglimin is used to treat type-2 diabetes (T2D).The chiral stationary phase was reverse phase Chiralpak IG-3 (100 × 4.6 mm, 3 µm), whereas the isocratic mobile phase was methanol and 10 mM ammonium acetate (95:5 v/v ratio) and the flow rate was 0.5 ml/minutes.The resolution of the (+) and (-) enantiomers was monitored using LC-ESI-MS/MS in positive transition at 155.0 m/z (M+H) for imeglimin.The (+) and (-) linearity ranges from 10 to 100 ng/ml.The correlation co-efficient (R 2 ) of the (+) and (-) imeglimin enantiomers was found to be linear.The retention time of the (+) and (-) enantiomers of the drug was 2.876 and 4.325 minutes and the total run time of the chromatographic resolution was 5 minutes.As a result, our goal is to separate the enantiomers and develop a fast, sensitive, and cost-effective method for estimating (+) and (-) enantiomers in its formulation.