title: Liquid chromatographic estimation of (S) - glycidyl butyrate in (R) - glycidyl butyrate.
abstract: OBJECTIVE
  The present study was undertaken out of a commercial need for the synthesis of Linezolid with impurity limits within the specification.
  
  
  METHODS
  (R)-Glycidyl butyrate (RGB) is raw material for the synthesis of Linezolid drug substance. This RGB contains (S)-(+)-Glycidyl butyrate (SGB) and SGB appears in same concentration in the final Active Pharmaceutical Ingredient. So, a normal phase high-performance liquid chromatography (HPLC) method has been developed to determine the SGB level in the raw material. RGB and SGB were separated using an HPLC system equipped with quaternary gradient pumps on a Daicel chiralpak AD-H (250 × 4.6 mm) column with a mobile phase consisting 2.0 ml of ethanol in 1 000 ml of n-hexane. A 0.5 ml/minute flow rate and a 10 μl injection volume was used and the compounds were detected at 215 nm.
  
  
  RESULTS
  Method validation parameters demonstrated the same to be reliable, reproducible, and accurate one.
  
  
  CONCLUSIONS
  Thus, the present study may be used for regular quality control of RGB to improve commercial feasibility for the synthesis of Linezolid.
authors.affiliation: Analytical Research Laboratory, Glenmark Research Center, Glenmark Generics Limited Navi Mumbai, Maharashtra, India.
authors.forename: Mubeen Ahmad
authors.initials: MA
authors.lastname: Khan
authors.forename: Sukumar
authors.initials: S
authors.lastname: Sinha
authors.forename: Nandkumar
authors.initials: N
authors.lastname: Khandekar
authors.forename: Vikas
authors.initials: V
authors.lastname: Parashar