In vitro Comparative Quality Evaluation of Different Brands of Marketed Paracetamol Tablets Available in Bangladesh

Abstract

Aim: This study was performed to evaluate the quality of five brands of Paracetamol 500mg tablets from different manufacturers. Methods: The general quality parameters of these tablets like weight variation, hardness, thickness, diameter, friability, disintegration time and also dissolution time were evaluated according to the established protocols. For measuring weight variation, an electric analytical balance was used. The hardness, thickness and diameter were determined by an automated hardness tester. Friability was measured by a friabilator. Disintegration time and dissolution time were analyzed by disintegration apparatus and dissolution tester respectively. Results: In this study, all the five brands of the tablets passed the BP or USP standards for in vitro evaluation tests with a very slight deviation. All brands complied with the standards for weight variation (550.1±5.88 mg to 631.1±4.71 mg), hardness (121.60±6.6 N to 220.20±7.6), disintegration time (3 minutes 15 seconds to 5 minutes 30 seconds). However, in case of friability, although brand A showed slight deviation, the remaining had shown the satisfactory results with the standard. In addition, the drug release rate of different brands of paracetamol was satisfactory within 30 minutes and ranged from 90.88% to 103.75%. Conclusion: It can be concluded that almost all the tablets of paracetamol purchased from retail outlets in Bangladesh are manufactured and marketed according to GMP. Further work is recommended on bioequivalence of these tablets.