A NP-HPLC method was established for the chiral separation and determination of the enantiomer (2) of apremilast (1). A Daicel Chiralpak IF column was used, with the mobile phase of hexane∶ethanol∶isopropanol∶ diethylamine (30∶40∶30∶0.1) at the detection wavelength of 232 nm. It was linear for 2 in the range of 1.0—10 μg/ml. Its LOD was 0.084 μg/ml, and average recovery was 99.1％, with RSD of 1.59％. In addition, a NP-HPLC method was established for the chiral separation and determination of the intermediate of the enantiomer (4) in apremilast (3). A Daicel Chiralpak IF column was used, with the mobile phase of hexane∶isopropanol∶diethylamine (50∶50∶0.1) at the detection wavelength of 232 nm. It was linear for 4 in the range of 2.0—10 μg/ml. The LOD was 1.012 μg/ml. Its average recovery was 98.9％, with RSD of 3.20％.
Key words
apremilast /
intermediate /
enantiomer /
HPLC /
chiral separation /
content determination
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References
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Footnotes
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