Abstract
The availability of several brands of spironolactone tablets in Bangladeshi pharmacies today places health practitioners in a problem of generic substitution. The purpose of this research work was to evaluate the pharmaceutical equivalent of six different brands of spironolactone 25 mg tablets using various pharmacopoeia and non-pharmacopoeia tests with special landmarks on in vitro dissolution study and with different price ranges purchased from retail pharmacies of Bangladesh. Assay of spironolactone tablets revealed that all samples contained 95.11-102.88% of labeled potency. In vitro drug release pattern was more than 85% in case of all brands in the medium within an hour of the test. The dissolution profiles were compared with the use of model independent approaches of difference factor and similarity factor; showing that only brand SPL2 is recommended to be used as alternative to reference brand SPL1. Results from the study have shown that switching or substituting brands of spironolactone in patients should be guided by a critical assessment of the dissolution data using appropriate evaluation techniques.
