A normal phase, isocratic LC method was developed for the separation of pos
itional isomers of celecoxib (I) using a chiral column, Chiralpak-AD. The m
ethod is useful for the quantification of ortho (II) and meta (III) forms i
n bulk drugs and formulation samples of celecoxib. The method has been comp
letely validated and proven to be rugged, The limit of detection (LOD) and
limit of quantitation (LOQ) of ortho and meta forms were found to be 38 ng
and 116 ng respectively. The active pharmaceutical ingredient was extracted
from its finished dosage form (capsule) using ethanol. The percentage reco
veries of ortho isomer was found to be 99.8-102.7 and 97.8-103.2 and the pe
rcentage recoveries of meta isomer was found to be 99.3-102.6 and 99.7-104
in spiked bulk and formulation samples of celecoxib respectively. (C) 2001
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