Comparative in vitro Evaluation of Three Brands of Hydrochlorothiazide Tablets in Libya

Abstract

Hydrochlorothiazide (HCTZ) is a diuretic of the thiazide class, which is used in the treatment of hypertension, edema, congestive heart failure, and different forms of renal and hepatic dysfunction. The aim and the objective of our present study are to evaluate the quality parameters of some marketed hydrochlorothiazide tablets and to compare the parameters among them. To assess the quality, three different marketed hydrochlorothiazide 25 mg tablets available on private pharmacies of Tripoli, Libya, are selected, and in vitro dissolution test, potency, and disintegration time are carried out. Other general quality parameters of these tablets, like weight variation, hardness, and friability, are also determined according to established protocols. All the brands comply with the requirements of the United States Pharmacopoeia as they show an acceptable weight variation range. Friability of Brand A brands is more than 1% so it does not pass the friability test. The hardness of all brands was below 4 kg/cm^2. The limitation of the potency must be within 92.5- 107.5%. All three brands meet this specification. The mean disintegration times of all tested brands were within the pharmacopeia specification (30 minutes). In the case of dissolution profile, all brands show better dissolution time as they release more than 90% of the drug in 30 minutes. The difference factor (f1) and similarity factor (f2) values revealed that all brands maintained the quality and complied with the USP specifications, and are like the comparator product and could be used interchangeably in clinical practice