Publication: Simultaneous determination of R-(-)-, S-(+)-baclofen and impurity A by electrokinetic chromatography
Issued Date
2010-02-05
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07317085
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2-s2.0-70350596216
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of Pharmaceutical and Biomedical Analysis. Vol.51, No.3 (2010), 541-548
Suggested Citation
Leena Suntornsuk, Suphutcharasa Ployngam Simultaneous determination of R-(-)-, S-(+)-baclofen and impurity A by electrokinetic chromatography. Journal of Pharmaceutical and Biomedical Analysis. Vol.51, No.3 (2010), 541-548. doi:10.1016/j.jpba.2009.09.005 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/28784
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Title
Simultaneous determination of R-(-)-, S-(+)-baclofen and impurity A by electrokinetic chromatography
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Abstract
A rapid method for the simultaneous analysis of R-(-)-, S-(+)-baclofen and impurity A, (4RS)-4-(4-chlorophenyl) pyrrolidin-2-one, by electrokinetic chromatography was established. The optimized condition was in 100 mM sodium borate buffer (pH 9.9) containing 18 mM α-cyclodextrin (CD) and 1% (v/v) ACN using a fused-silica capillary dynamically coated with polyethylene oxide (PEO), with an effective length of 56 cm and an inner diameter of 50 μm, hydrodynamic injection at 50 mbar for 6 s, temperature of 45 °C, applied voltage of 27 kV and UV detection at 220 nm. Baseline separation of all analytes was achieved within 9 min (Rs> 2.7) with the migration order of impurity A, S-(+)- and R-(-)-baclofen. The method showed good linearity (r2> 0.999 in a range of 5-50 μg/mL for impurity A and 50-500 μg/mL for baclofen enantiomers), precision (%RSDs < 3.37%) and recoveries (100.3% for R-(-)-baclofen, 101.6% for S-(+)-baclofen and 96.1% for impurity A). Detection and quantitation limits were 10 and 30 μg/mL for both enantiomers, and 2 and 5 μg/mL for the impurity, respectively. The method was efficient for the determination of baclofen enantiomers and impurity A in pharmaceutical raw material and formulations due to its reliability, speed and simplicity. © 2009 Elsevier B.V. All rights reserved.