A Sensitive and Specific Analytical Method for Determination of Diclofenac Sodium Using High-Performance Liquid Chromatography

Abstract

Diclofenac Sodium (DCL-Na) is a widely prescribed nonsteroidal anti-inflammatory drug (NSAID) used to treat conditions such as rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, and gout. This study aims to develop and validate a simple, precise, and accurate high-performance liquid chromatography (HPLC) method for quantifying DCL-Na in pharmaceutical formulations. The method utilizes a Supelcosil C-18 column with a mobile phase consisting of potassium dihydrogen phosphate solution and acetonitrile. The method validation follows International Conference on Harmonization (ICH) guidelines, evaluating precision, accuracy, specificity, linearity, and range parameters. The developed method demonstrated excellent linearity with an R² value of 0.9996 over a concentration range of 5-50 μg/ml, and the limits of detection (LOD) and quantification (LOQ) were found to be 6.634 μg/ml and 22.114 μg/ml, respectively. Intraday and interday precision tests showed relative standard deviations (% RSD) well within acceptable ranges. The method's practical applicability was confirmed through the analysis of controlled-release tablets, which showed a release of approximately 80% of DCL-Na after 20 hours. This validated HPLC method is suitable for routine quality control of DCL-Na in pharmaceutical products.