• Archives of Pharmacal Research
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• v.27 no.8
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• pp.820-824
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• 2004

An optical purity test was indirectly performed on (S)-ibuprofen as its diastereomeric (R)-(+)-1-phenylethylamide derivative using achiral gas chromatography (GC). The method for the determination of trace (R)-ibuprofen (optical impurity), within the range 1.0 to 50 ng, from a racemic ibuprofen standard was linear (r＝0.9997) with acceptable precision (％ $RSD{\leq}5.3$) and accuracy (％ RE＝0.7~-3.9). Similar results were obtained with the method validation for the quantification of (S)-ibuprofen within the range 0.1 to 2.0 $\mu\textrm{g}$ using a (S)-ibuprofen stan-dard. When applied to seven different commercial (S)-ibuprofen products, their optical purities (98.7~99.1％) were determined with good precision (％ $RSD{\leq}4.0$).