In vitro Comparative Quality Assessment of Different Brands of Hydrochlorothiazide Tablets Marketed in Northeast Ethiopia

Abstract

Abstract Background This study aimed to evaluate the quality and physicochemical bioequivalence of commercially available brands of hydrochlorothiazide 25mg tablets in community pharmacies in Dessie town, Northeast Ethiopia.Methods Experimental-based cross-sectional study design was applied using disintegration, identification, friability, uniformity, hardness, and assay test methods as described in the USP. Difference (f1) and similarity (f2) factor values were calculated to assess in vitro bioequivalence of generic products with the comparator.Result The study revealed that all investigated brands of hydrochlorothiazide tablets contain a genuine active pharmaceutical ingredient (API) in their formulations. The friability test result was concordant with the USP (< 1%) in eight of the investigated brands. Whereas the result of the hardness limit was concordant (39.23N, USP 2019) in only six of those brands. The weight variation test result indicated that all samples complied with USP specification limits. The quantitative assay result of API was within the limit of USP (90% up to 110%). Similarly, all samples meet the disintegration time limit (i.e, ≤ 30 minutes) and drug-releasing tolerance limit (API released more than 60% within 60 minutes). The f2 values were > 50 & f1 values were ˂15 for all sampled brands of hydrochlorothiazide tablet formulations.Conclusion The majority of sampled brands of hydrochlorothiazide 25 mg tablets met the quality requirements as per USP official test specifications limit. From similarity factor (f2) and difference factor (f1) values, all studied brands were equivalent to the comparator and can interchangeably use in the clinical area.