Reverse‐phase chiral high‐performance liquid chromatography for separation of a diastereomer in alalevonadifloxacin: A novel antibacterial agent. (7th February 2021)

• Record Type: Journal Article
• Authors: Ahirrao, Vinod; Rane, Vipul; Patil, Kiran; More, Kiran; Jadhav, Rajiv; Yeole, Ravindra
• Is Part Of: Biomedical chromatography. Volume 35:Number 6(2021)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2021-02-07
• Subjects: alalevonadifloxacin -- antibacterial agent -- method validation -- Pirkle‐type stationary phase; Chromatographic analysis -- Periodicals; Biology -- Periodicals; Medicine -- Periodicals; Biology -- Periodicals; Chromatography -- methods -- Periodicals; Medicine -- Periodicals; 543.089
• DOI: 10.1002/bmc.5079
• Languages: English
• ISSNs: 0269-3879

Abstract

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.