Comparison of Chemical Parameters of Different Brands of Rivaroxaban Tablets Available in Pakistan

Abstract

A major issue is that the dissolution and assay methods are not discussed in any pharmacopeia, so the assay method was developed following the guidelines of the Food and Drug Administration. The analytical and dissolution methods were developed and validated in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) guidelines. This study aims to discover the presence of counterfeit or substandard drugs in the market, to classify the most compliant brands, and to ascertain the appropriateness of interchangeability. Four different brands of rivaroxaban were selected in order to perform different quality control tests, which included the analytical, dissolution, and assay methods in accordance with the guidelines of the United States Pharmacopeia. The four chosen brands were tested and the results were found to be compliant with chemical parameters such as dissolution, content uniformity, and assay. Hence, it can be concluded that rivaroxaban 10 mg tablets, manufactured in Pakistan by leading pharmaceutical companies, are consistent in quality and can be easily interchangeable.