Vol. 6, Issue 3 (2017)

Author(s):
James Regun Karmoker, Rubayia Jahan Priya, Shuvro Sarkar and Swarnali Islam

Abstract:
The presence of numerous generic brands of gliclazide in the local drug market makes the situation difficult for health professionals and patients to choose the appropriate product. This study was intended to evaluate the bioequivalence of six marketed brands of gliclazide (80 mg) tablets from different manufacturers using in vitro dissolution study in order to minimize health risk factors. Drug releases were compared with that of a reference product. The dissolution profiles showed intra brand and inter brand variability. All the brands achieved 85% dissolution within 45 minutes. Test results were subjected to statistical analysis to compare the dissolution profile. Limit of detection (LOD) and limit of quantification (LOQ) were also calculated. Model independent approaches of difference factor (f₁), similarity factor (f₂) and dissolution efficiency (%DE) were employed. Using a validated UV spectrophotometric method, active ingredients were assayed. Assay value was recorded within 97.75% to 109.5%. Other general quality parameters of these tablets like diameter, thickness, hardness, friability, weight variation, disintegration time were also evaluated according to the established protocols and test results were within the limit.