1. Determination of Optical Impurity of Pregabalin by HPLC with Pre-Column Chiral Derivatization
- Author
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Jie Deng, Daolin Zhang, Xiaotai Fu, and Xiaohui Chen
- Subjects
Detection limit ,Chromatography ,Molecular Structure ,Pregabalin ,Analytical chemistry ,Reproducibility of Results ,Stereoisomerism ,General Medicine ,Repeatability ,Amides ,High-performance liquid chromatography ,Analytical Chemistry ,chemistry.chemical_compound ,chemistry ,Impurity ,Enantiomer ,Derivatization ,Acetonitrile ,Phosphoric acid ,Chromatography, High Pressure Liquid ,gamma-Aminobutyric Acid - Abstract
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.
- Published
- 2008
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