Pharmaceutical equivalence of Hydrochlorothiazide tablets in Argentina

Abstract

Hydrochlorothiazide (HCTZ) is a diuretic used to treat hypertension, which belongs to Class III of the Biopharmaceutics Classification System. The present study aimed to evaluate critical quality parameters of HCTZ solid oral dosage forms on the Argentine pharmaceutical market. For this purpose, evaluation of labels and patient information leaflets, description and mean weight of tablets, uniformity of dosage units, assay, hardness, friability, disintegration and dissolution tests were carried out, in compliance with the Argentine Pharmacopeia. The dissolution efficiency (DE) was obtained from the area under the drug dissolution curve, and the profiles were compared statistically by ANOVA. All samples met criteria for the assay, uniformity of dosage units, friability, hardness, disintegration tests, and dissolution test in Stage 1. Sample D presented the lowest dissolution performance, in terms of DE values, with highly significant differences in comparison with the rest of the evaluated samples; however, the results of this study indicate that HCTZ tablets available in Argentina successfully pass all established quality control tests and can be considered pharmaceutical equivalents.