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Development and Validation of A High-Performance Liquid Chromatographic Method with Ultraviolet Detection for Quantitation of Lornoxicam in Human Plasma: Application to Bioequivalence Study

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Author(s): Utpal Nandi, Bapi Gorain, Hira Choudhury, Bikash Roy and Tapan K Pal*

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 9;
Start page: 3203;
Date: 2011;
Original page

Keywords: Lornoxicam | High performance liquid chromatography | Plasma analysis | Pharmacokinetics | Bioequivalence study.

ABSTRACT
A simple, rapid and feasible high-performance liquid chromatographic method with ultraviolet detection has been developed and validated according to the FDAguidelines for the quantitation of lornoxicam in human plasma. Sample was prepared by simple liquid-liquid extraction. The chromatographic separation wascarried out in a Hypersil BDS, C18 column (250 mm × 4.6 mm; 5 μm particle size). The mobile phase was a mixture of 10 m mol phosphate buffer (KH2PO4)of pH 6.0 and acetronitle (55:45, v/v) at a flow rate of 1.0 mL/min. The UV detection was set at 290 nm. The method was specific and sensitive with lowerlimit of quantification (LLOQ) of 25 ng/mL. The accuracy and precision values obtained from six different sets of three quality control (QC) samples alongwith LLOQ analyzed in separate occasions ranged from 95.06%-99.82% and 1.014%-3.384%, respectively. The extraction recovery of lornoxicam in plasmasamples at three QC samples along with LLOQ was above 94.67%. In stability tests, lornoxicam in human plasma was stable during storage and assay procedure.The developed and validated method was successfully applied to quantitative determination of lornoxicam in plasma for the bioequivalence study in 12 healthyhuman volunteers following a single dose of lornoxicam 16 mg sustained release tablet.

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