Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization.
A new method for determining the optical impurity of Pregabalin is developed. The method is based on Pregabalin, and its isomers can be derivatized with Na-5-fluoro-2,4-dinitrophenyl-5-L-alanine amide. These derivated compounds can be separated by an ordinary chromatography column (Inertsil ODS-2.5 microm, 250 mmx4.6 mm i.d.). Phosphoric acid buffer and acetonitrile (55:45, v/v) are used as mobile phase and 1.0 mL/min flow rate at room temperature. The detective wavelength is fixed at 340 nm. The results indicate that the limit of detection of R model optical impurity 1.1x10(-8) g/mL (signal-to-noise=3), accuracy, and repeatability is satisfied. Therefore, the method can be used for the quality control of Pregabalin.
Chen
Xiaohui
X
The Faculty of Materials Science & Chemical Engineering, China University of Geosciences, No. 388 Lumo Road, Wuhan 430047, Hubei Province, PR China. vactyy@hotmail.com
Zhang
Daolin
D
Deng
Jie
J
Fu
Xiaotai
X
D000577:Amides / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D015394:Molecular Structure; D000069583:Pregabalin; D015203:Reproducibility of Results; D013237:Stereoisomerism; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry
D000577:Amides; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid