Pharmaceutical equivalence study of marketed ibuprofen tablets of UAE using a validated RP-HPLC method

Abstract

This study was carried out on the development of the RP-HPLC method and its application in the pharmaceutical equivalence study of ibuprofen tablets that are commercially available in the United Arab Emirates pharmaceutical markets. Three local and six imported brands of ibuprofen tablets were included in this study. The physical parameters of all products were recorded. An RP-HPLC system was developed and validated for the identification and quantification of the ibuprofen present within the tablets. The dissolution study was carried out using both UV-spectrophotometry (United State Pharmacopeia 42-National Formulary-37) and the RP-HPLC method with eight sampling data points. The dissolution profiles of eight test products were compared with a reference product (Switzerland), and similarity/difference factors were calculated. The developed RP-HPLC method was simple, precise, and suitable for the quantification of ibuprofen present within the tablets. The studied products contained 97.46%–107.58% ibuprofen. The products released about 92.44%–110.63% ibuprofen within 60 minutes except one imported product that released only 12.51% of the drug. Based on similarity factor reference ranges (50%–100%), three products exhibited more than 50% similarity in dissolution profiles. In conclusion, the studied products passed the test for physical parameters, drug contents, and dissolution study except for an imported product. Based on calculated similarity factors, three products were a pharmaceutical equivalent to the reference product in respect to dissolution profiles comparison.