Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization.

Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization. Research Abstract Details 

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Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization. Abstract Text:

Xiaohui Chen,Daolin Zhang,Jie Deng,Xiaotai Fu,

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 N(a)-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 mm x 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 x 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.

Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization. Publishing Authors By Initials

X Chen,D Zhang,J Deng,X Fu,

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Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Journal of chromatographic science

VOLUME: 46

Page Numbers: 42-4

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ISSN: 0021-9665

DAY: 25

MONTH: Jan

YEAR: 2008

Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization. Information

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LANGUAGE: eng

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Grant and Affiliation Information for Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization.

AFFILIATION: The Faculty of Materials Science & Chemical Engineering, China University of Geosciences, No. 388 Lumo Road, Wuhan 430047, Hubei Province, P.R. China.

Country: United States

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MEDLINETA: J Chromatogr Sci

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