Bioanalytical Method Development and Validation of Naproxen: Application to Bioequivalence Studies

A new selective and sensitive high-performance liquid chromatography method was developed for the quantification of Naproxen in human plasma using diclofenac sodium asinternal standard (IS). Chromatographic separation was achieved on aPhenomenex GEMINI C18 (150 x 4.6 mm, 5 mm) column. The mobile phase consists of a mixture of Acetonitrile: 0.5% Triethylamine buffer (50:50; v/v) and the pH of the mobile phase was adjusted to 3.5 by 85 % orthophosphoric acid. Flow rate of mobile phase was 1 mL/min.Detection was performed at 230nm. The calibration curve was linear over the concentration range from 10 to 120µg/mL. The detection (LOD) and quantification (LOQ) limits were 10 ng/mL and 25 ng/Ml respectively. The method was validated for accuracy, precision, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines.The developed method for the determination of Naproxen from human plasma has been found accurate, precise, selective, and suitable for the bioequivalence and pharmacokinetic studies.