SADMAN S B RASHED, RAZWANUR R TUSHAR, FAİRUZA AHMED, NUSRAT J VABNA, LAİLA JAHAN, MOHAMMAD M BILLAH
Acta Pharmaceutica Sciencia - 2021;59(4):641-653
This study was aimed to assess the pharmaceutical equivalence of four brands of clonazepam tablets available in Bangladesh using in vitro dissolution study by UV spectrophotometry. Dissolution study in water was carried out using USP type-2 paddle apparatus. Other quality control tests like weight variation, disintegration time and assay were also performed according to the established methods. Almost all the samples attained 85% drug dissolution within 15 minutes. The assay revealed that all brands contained around 94-107% (w/w) of labeled chemical content. All brands complied with the official specifications for disintegration time. Dissolution results of all the test products were compared to that of the reference product with difference factor (f1) and similarity factor (f2). Apart from brand B, the dissolution profiles of other brands showed no significant variations. The study indicates that brands C, D and E were equivalent to the reference brand A so they may be prescribed interchangeably.
