Abstract

Validated RP-HPLC method for determination of dexibuprofen: Application in pharmaceutical dosage and human serum

Author(s): Najmul Hasan, Mathurot Chaiharn, Zulfiqar Ali Mirani, Naveed Ahmed Qambrani

A novel stability indicating, specific, precise and accurate, high performance liquid chromatographic method has been developed and validated for the determination of Dexibuprofen in pharmaceutical dosage forms of capsules and tablets, and in human serum.Acetonitrile: Buffer:AceticAcid 0.1M(65:35:0.3 v/v/v) was themobile phase at flowrate 1.0ml/min using a Hibar® ìBondapak® C18 column monitored at wavelength of 220nm. The calibration curve was linear with a correlation coefficient of more than 0.9995 for the drug. The averages of the absolute and relative recoveries were found to be 100.07%for Dexibuprofenwith 10ng/ml limit of quantification and 3ng/ml limit of detection. The drug was subjected to stress conditions of hydrolysis (acid, base, oxidation, and thermal degradation). Maximum degradation was observed in base and 35% H2O2 while found relatively stable in the other stress conditions. The studies of forced degradation prove the stability indicating power of the method. The developed method was validated in accordance to ICH guidelines. The proposed High-performance liquid chromatographic method was successfully applied to quantify the amount of Dexibuprofen in bulk, dosage form and physiological fluid.