Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
46, Number 1, January 2008, pp. 42-44
Determination of Optical Impurity of Pregabalin
by HPLC with Pre-Column Chiral Derivatization
Xiaohui Chen[1], Daolin Zhang[2], Jie Deng[2],
and Xiaotai Fu[2]
[1]The Faculty of Materials Science & Chemical Engineering,
China University of Geosciences, No. 388 Lumo Road, Wuhan 430047,
Hubei Province, P.R. China and
[2]Chongqing Pharmaceutical Research
Institute CO., LTD. Chongqing 400061, P.R. China
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 µm, 250 mm ¥ 4.6
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 1.1 ¥ 10–8
g/mL (signal-to-noise = 3), accuracy, and repeatability is satisfied.
Therefore, the method can be used for the quality control of
Pregabalin.
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