LC separation of ortho and meta isomers of celecoxib in bulk and formulations using a chiral column

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 Elsevier Science B.V. All rights reserved.