Abstract: A Chiral high-performance liquid chromatographic (HPLC) method was developed and validated for the enantiomeric separation of glycidyl butyrate and the quantification of S (+)-glycidyl butyrate. Separation was achieved on Chiralcel OD-H (250 × 4.6mm, 5μ) column using a mixture of Hexane: 2-Propanol (100:1, v/v) as a mobile phase with flow rate of 1.0 mL/min on UV detector. The resolution between S (+)-glycidyl butyrate (SGB) and R (-)-glycidyl butyrate (RGB) enantiomers was found to be more than 2. The proposed method was validated with respect to linearity, precession, accuracy, limit of detection (LOD), limit of quantitation (LOQ) and robustness. The SGB showed an excellent linearity over the concentrations range from 2 to 24 μg/mL, while the mean recovery..........
[1]. Maier, N.M., Franco, P., Lindner, W., Separation of enantiomers: needs, challenges, perspectives, J Chromatogr A., 2001, vol.906, no.1, p. 3-33.
[2]. Wrezel, P.W., Chion, I., Pakula, R., Weissmueller, D.W., System suitability and validation for chiral purity assays of drug substances, LC GC North America., 2006, vol.24, no.11, p.1216-1221.
[3]. Cupps, T., Fritschel, B., Mavroudakis, W., Mitchell, M., Ridge, D., Wyvratt, J., Starting material, reprocessing, retesting, and critical controls, Pharm Technol., 2003, vol.27, no.2, p.34-53.
[4]. United States Food and Drug Administration, Center for Drug Evaluation and Research. Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances, 1987.
[5]. United States Food and Drug Administration, Center for Drug Evaluation and Research. Q11 Development and manufacture of drug substances, 2012..