Paper Key : IRJ************025
Author: Kapade Aishwarya Chandrakant,Muktapure Vaibhavi Vitthalt,Karad Shrinivas Yashwant,Ingale Sayli Maruti
Date Published: 01 Mar 2025
Abstract
The present study aims to compare the pharmaceutical equivalence of the same Losartan potassium tablets of different brand manufacturers that are available in the drug market. Six brands of commercial available Losartan potassium film tablets containing 50 mg of Losartan potassium were used in this study. Quality control tests were evaluated for Losartan potassium film tablets. All commercial Losartan potassium film tablets met the criteria specified by quality control test parameters. The dissolution profile was carried out using the apparatus II according to USP guidelines. All different formulations meet the acceptable limits with the official monographs for the quality control tests. The dissolution profiles showed variation between brand to brand drugs. The assay was calculated by using the absorbance 205 nm. All samples attained more than 70% dissolution media within 60 minutes. The result was subjected to statistical analysis is to compare dissolution profiles of different Marketed products. The In Vitro dissolution study was carried out with the six brands of 50 mg Losartan Potassium tablets according to FDA dissolution method. The process was done for 2 tablets of each brand; using 900 ml of pH 1.2 0.1 N HCl and pH 6.8 Phosphate Buffer separately as dissolution media; 50 rpm as rotation speed; 37C 0.5C as media temperature; 10, 15, 20, 30, 45 and 60minutes as sample collection time points. The results were carried out by interpreting data on the % Drug release there were significant differences in the dissolution profiles of the six brands specially when considered according to different media. In pH 1.2 0.1 N HCl all brands showed poor drug release, pH 6.8 Phosphate Buffer gave best results for drug release of most of the brands. The results show the need for constant monitoring of new brands of Losartan Potassium introduced into the drug market to ascertain bioequivalence and conformity with pharmacopoeia standards.