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A simple bioanalytical assay for determination of loxoprofen in human plasma: Application to a pharmacokinetic study

Marwa Hosny Tammam, Nisreen Farouk Abo-Talib, Essam Ezzeldin

A simple, rapid, sensitive and accurate HPLC-UV detectionmethod for the quantification of loxoprofen sodium (Lox) in human plasma has been developed and validated. Diclofenac potassium(Dic) was employed as internal standard (I.S). The analytes were chromatographically separated on Agilent eclipse ODS C18 column (150 x4.6 mm, 5µm) with mobile phase consisting of phosphate buffer pH 2.5: acetonitrile (55:45, v/v). Detection was performed with UV detection at 320 nm. Calibration curves for Lox in plasma was linear over concentration ranges of 0.06-10.00 µg /ml with inter-assay coefficients of variations (CV %) less than 10 % in the plasma and with correlation coefficient of 0.999. The average recoverywas 90.00%. The LLODand LLOQ are 0.04 and 0.06 µg / ml, respectively. This method was utilized successfully for the analysis of plasma samples following oral administration of Lox (60 mg) in 6 healthy male human volunteers under fasting conditions. The results obtained indicated that this method is suitable for pharmacokinetics and bioavailability studies.