Reverse‐phase chiral high‐performance liquid chromatography for separation of a diastereomer in alalevonadifloxacin: A novel antibacterial agent

Abstract

Alalevonadifloxacin (ALA) is a novel antibacterial drug, recently launched in India to treat infections caused by Gram‐positive bacteria. In present work, a chiral high‐performance liquid chromatographic method was developed and validated for the quantification of a diastereomeric impurity (DI) in ALA. The separation was achieved on Pirkle type (R,R) Whelk‐O1 chiral stationary phase, using ammonium formate buffer and acetonitrile in gradient fashion at a flow rate of 1.5 ml/min. The method was extensively validated for the quantification of DI in ALA. The detector response for DI was linear over the concentration range of 0.24–4.78 μg/ml. Limit of quantitation and limit of detection for DI were 0.24 and 0.07 μg/ml respectively. The mean recovery of the DI was 103.47 ± 5.14%. The impact of column temperature on the chiral separation was evaluated. The method was employed for controlling diastereomeric impurity in the batches of ALA used in preclinical studies.

Diasterieomeric Separation of a Novel Chalcone Derivative by Chiral HPLC

“…Most analytical separations for enantiomers are performed by using chiral columns. However, there are fewer attempts to separate the diastereomers by using these type of columns [8]. There is a diastereomer separation method available either by using the silica gel on a column or diastereomeric ionic crystals, e.g., acid/amine, or inclusion complex crystals are fractionally recrystallized.…”