Mubeen Ahmad Khan, Sukumar Sinha, Nandkumar Khandekar, Vikas Parashar
Analytical Research Laboratory, Glenmark Research Center, Glenmark Generics Limited, Navi Mumbai, Maharashtra, India.
DOI: 10.4103/0976-9668.92331

ABSTRACT

Aim: The present study was undertaken out of a commercial need for the synthesis of Linezolid with impurity limits within the specification. Materials and 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. Conclusion: Thus, the present study may be used for regular quality control of RGB to improve commercial feasibility for the synthesis of Linezolid.

Keywords: (R)–Glycidyl butyrate, (S)–(+)–glycidyl butyrate, chiral–HPLC, Linezolid, validation.