A Comparative In-Vitro Study for Evaluation of Physicochemical Properties of the Domestic and Innovator Brands of Sertraline Hydrochloride Tablets Available in the Iranian Market

Abstract

Background: The present study was aimed to assess the quality of Iranian and innovator sertraline hydrochloride (SER) tablets available in the Iranian market. This study could make it possible to provide adequate evidences confirming the similar physicochemical quality of Iranian and imported SER products and could subsequently decrease the therapy costs owing to the more affordable costs of Iranian medicines compared to the imported ones. Methods: Seven products including one imported and six Iranian SER tablet brands were purchased from local pharmacy stores in Tabriz. Quantification of the amount of active ingredient in assay, uniformity of dosage units and dissolution tests were performed using an HPLC method recommended by USP monograph and other physicochemical properties were assessed in accordance with the USP general recommendations. Results: According to the obtained results, the amount of active ingredient in all the products met the acceptable range (%90 - %110); the content of all the studied products was uniform (AV ≤ 15); and all the products passed the dissolution test at the first stage (Q30 ≥ 85 %); the average weight of all the products was uniform with RSD% of less than 5%; except for one product with friability of 15.8% (due to the coating issue), all products' hardness (≤ 10 Kg) and friability (≤ 1%) were acceptable and all of them completely disintegrated after 30 min. Conclusion: The results of this study illustrated the acceptable quality of the most Iranian brands of SER compared to the innovator brand regarding the studied physicochemical properties. 

Keywords: Sertraline hydrochloride, Post-marketing, Quality control, Physico-chemical properties, Tablet