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Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF FLURBIPROFEN IN TABLET DOSAGE FORM BY LIQUID CHROMATOGRAPHY

B. Rajani*, G. Bangar Raju, K. Mukkanti

A simple reversed-phase high performance liquid chromatography (HPLC) method for the determination of Flurbiprofen in pharmaceutical dosage form was developed and validated. The chromatographic separation was achieved on Hypersil BDS (100 x 4.6 mm, 5?) column. The mobile phase, 0.01 M potassium dihydrogen phosphate buffer and acetonitrile (52:48) were delivered at a flow rate of 1.0 ml/min. The eluent was monitored using PDA detection at 246 nm. Validation parameters such as system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), Stability of sample and standard stock solutions and robustness were studied as reported in the International Conference on Harmonization guidelines. The retention time for Flurbiprofen was 3.1 min. The calibration graph for Flurbiprofen was linear from 12.5 to 75 µg/mL. The interday and intraday precisions (relative standard deviation) were less than 1.0. The method can be employed for routine quality control of Flurbiprofen tablets in quality control laboratories and pharmaceutical industries.


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