In-Vitro Evaluation of Different Brands of Desloratadine Tablets Available in Bangladeshi market

Abstract

Abstract: Desloratadine, a long acting antihistamine with high selectivity for peripheral histamine H1- receptors has a rapid onset of action and a duration of action of 24-hours. Due to difference in the formulation process for different brands different physicochemical properties may vary which ultimately leads to change in the efficacy and duration of action of the drug when given orally. The aim of this study was to analyze the quality and stability of desloratadine 5mg tablet by evaluating various in-vitro parameters. For this purpose, five different brands from different pharmaceutical companies of Bangladesh were collected. The quality control parameters including weight variation, hardness, friability, disintegration test and dissolution test were performed to get a comparison between these marketed products. As desloratadine is an INN (International Nonproprietary Names) drug, it has no specific dissolution method in USP (United State Pharmacopoeia) or BP (British Pharmacopoeia). So, a dissolution method listed by USFDA (United States Food & Drug Administration) was followed. Various results were obtained from the test and compared with the specifications. Minimum disintegration time was found 31 sec. Best Dissolution was shown 97.67% after 45 minutes. From the study, it can be concluded that the most brands of desloratadine tablets of the local brands have the desired and optimum therapeutic efficacy.