Pharmaceutical Study to Assess the Equivalence of the Commercial Brands of Losartan Potassium Tablets Available in Aden Governorate, Yemen
University of Aden Journal of Natural and Applied Sciences,
Vol. 28 No. 2 (2024),
18-04-2025
Page 75-85
DOI:
https://doi.org/10.47372/uajnas.2024.n2.a07
Abstract
Losartan potassium, a non-peptide angiotensin II receptor antagonist, is prescribed by the physicians for hypertension treatment. In Aden governorate, Yemen, losartan is available as oral tablets and tablets combining losartan potassium and hydrochlorothiazide. A study comparing generic brands of 50 mg Losartan potassium tablets to their reference brand was conducted to determine their pharmaceutical equivalency. The study involved quality control parameters and in vitro dissolution studies using the USP method. The results showed that the seven brands of losartan potassium tablets met the specified criteria for immediate-release tablets, with the drug content ranging from 95.69% ±1.97 to 99.62% ±1.57. The reference brand LC-1 and the generic brands LC-2 and LC-3 achieved fast drug dissolution of about 80% within 30 minutes, while the generic brands from LC-4 to LC-7 gave drug dissolution in the range of 76.09–78.07. The dissolution kinetics of the seven brands followed the Weibull model, with similarity factors exceeding 50%, differences in dissolution efficiencies less than 10%, and a mean dissolution time between 10.93 and 13.57 minutes. In conclusion, the commercially generic brands of Losartan potassium tablets were pharmaceutically equivalent and could be used interchangeably with the reference brand.
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Losartan potassium, Quality control, Brands, dependent drug modeling, independent drug modeling
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