https://doi.org/10.37229/fsa.fjms.2025.11.25

This study presents a comprehensive spectrophotometric evaluation of various brands of diclofenac sodium tablets obtained from community pharmacies in Misurata. Both physical and chemical characteristics were assessed to determine compliance with pharmacopeial standards and to ensure product quality. Physical analysis demonstrated that all tested brands met pharmacopeial requirements for weight uniformity, with individual tablet weights within accepted deviation limits. Tablet thickness and hardness were consistent across brands, confirming uniform compression and sufficient mechanical strength. Friability values for all samples were below 1%, indicating satisfactory resistance to abrasion. Disintegration tests showed all brands disintegrated within the pharmacopeial time limit, ensuring prompt drug release. Chemical analysis was performed using a validated UV spectrophotometric method. The method showed excellent linearity, with a correlation coefficient (R²) of 0.999 across the tested concentration range between 2.5 μg/mL – 20 μg/mL. The assay results indicated that the diclofenac sodium content in all brands ranged from 98.5% to 101.2% of the labeled claim, meeting pharmacopeial standards for content uniformity. The method demonstrated high precision, with relative standard deviation (RSD) values below 2% for repeated measurements. Recovery studies yielded mean recoveries between 99.1% and 100.4%, confirming the accuracy of the analytical procedure. Importantly, the limit of detection (LOD) was determined to be 0.404 μg/mL, and limit of quantitation (LOQ) was 1.225 μg/mL, indicating the method’s high sensitivity for diclofenac sodium quantitation in tablet formulations. In conclusion, all evaluated brands of diclofenac sodium tablets available in Misurata pharmacies conformed to pharmacopeial standards for both physical and chemical quality attributes. The validated spectrophotometric method proved to be accurate, precise, sensitive, and suitable for routine quality control of diclofenac sodium in pharmaceutical preparations.