Fundamental study of enantioselective HPLC separation of tapentadol enantiomers using cellulose-based chiral stationary phase in normal phase mode

A sensitive and specific high performance liquid chromatography method for the separation and determination of tapentadol enantiomers has been developed and validated. Ten different chiral columns were tested in a normal phase system. Excellent enantioseparation with the resolution more than 2.5 for...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2013-02, Vol.74, p.111-116
Main Authors: Douša, Michal, Lehnert, Petr, Adamusová, Hana, Bosáková, Zuzana
Format: Article
Language:English
Subjects:
additives
alkanes
Cellulose - analysis
Cellulose - chemistry
Chiral HPLC separation
Chiralpak AD-H
Chromatography, High Pressure Liquid - methods
detection limit
enantiomers
fluorescence
guidelines
high performance liquid chromatography
ingredients
Mobile phase optimization
Phenols - analysis
Phenols - chemistry
Stereoisomerism
Tapentadol
Validation
water content
wavelengths
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Summary:A sensitive and specific high performance liquid chromatography method for the separation and determination of tapentadol enantiomers has been developed and validated. Ten different chiral columns were tested in a normal phase system. Excellent enantioseparation with the resolution more than 2.5 for all enantiomers was achieved on Chiralpak AD-H using mixture of heptane–propan-2-ol–diethylamine (980:20:1, v/v/v). The detection was carried out using fluorescence detector at excitation wavelength of 295nm and emission wavelength of 273nm. The influence of mobile phase composition, namely organic modifiers, additives, aliphatic alkanes and water content in mobile phase, on retention and enantioseparation was studied. Validation of the developed method including linearity, limit of detection, limit of quantification, precision, accuracy and selectivity was performed according to the International Conference on Harmonization guidelines. The advantage of the method is a good enantioseparation, short analysis time (less than 20min) and therefore this method is suitable for routine determination of chiral purity of (R,R)-tapentadol in enantiopure active pharmaceutical ingredient.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2012.10.017