In vitro Pharmaceutical Quality Evaluation of different Ibuprofen tablet brands available on the Republic of Kosovo Market

Abstract

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that possesses anti-inflammatory, analgesic, and antipyretic effects and it is widely manufactured and marketed in the Republic of Kosovo. The study aims to evaluate the in vitro quality of three ibuprofen uncoated tablets 400mg formulations that are commercially most commonly used in the Republic of Kosovo markets. Ibuprofen tablets were tested for the uniformity of weight, disintegration time, friability, and analysis of the drug active content with the UV spectrophotometric and high-performance liquid chromatography (HPLC) method following comparisons with official protocols and pharmacopeia monograph. The weight uniformity testing and weight variation indicated no significant changes in the weight and variation among the analyzed brands' tablets. The friability values were <1 % and the disintegration times were between 3.87 and 10.01 min, which showed significantly variation for the first brand but all the samples meet official requirements (within 15 min for uncoated tablets). In addition, the results of the assay of chemical content using UV-VIS and HPLC analysis meet the official specification in the UV and HPLC assay methods (95-105% of active drug content). Our data indicated that the Ibuprofen tablet investigated in our study meets the in vitro quality control meets the official specifications, is chemically equivalent, and does not vary in physiochemical qualities.