Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
45, Number 8, September 2007, pp. 550-553
Chiral Separation of Two Pairs of Enantiomers
of Tadalafil by High-Performance Liquid Chromatography
Wenhui Gao[1], Zhefeng Zhang[2], Zhiwei Li[3],
and Guijian Liang[4]
[1]College of Biological Science and Engineering, HeBei University
of Science and Technology, Shijiazhuang 050018, China;
[2]Center
for Molecular Science, Institute of Chemistry, Chinese Academy
of Science, Beijing 100080, China;
[3]College of Chemical & Charmaceutical
Engineering, Hebei University of Science and Technology, Shijiazhuang
050018, China; and
[4]General Hospital of the Air Force PLA,
Beijing 100850, China
A high-performance liquid chromatographic method
was developed for the chiral separation of a new selective phosphodiesterase
5 inhibitors, tadalafil and its three isomers. The chiral separation
was performed on a Chiralpak AD column. The mobile phase was
hexane–isopropyl alcohol (1:1, v/v). UV detection was at
220 nm. Baseline chiral separation for the four isomers was obtained
within 30 min. Each of the resolutions of the two pairs enantiomers
were more than 2.0. The limits of quantitation were 0.60, 0.90,
1.20, and 1.80 ng for (6R, 12aS), (6R, 12aR), (6S, 12aS), and
(6S, 12aR) isomers, respectively. Relative standard deviation
of the method was below 2% (n = 5). The method is suitable in
quality control.
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