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ORIGINAL RESEARCH article

Front. Anal. Sci.
Sec. Pharmaceutical analysis
Volume 4 - 2024 | doi: 10.3389/frans.2024.1399843
This article is part of the Research Topic Thought Leaders in Analytical Science Research View all 4 articles

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

Provisionally accepted
Yehualashet T. Wondmkun Yehualashet T. Wondmkun 1*Haile K. Desta Haile K. Desta 2Yimer Seid Ali Yimer Seid Ali 2Abate W. Tsige Abate W. Tsige 1Bedilu Linger Bedilu Linger 1Samuel Berihun Samuel Berihun 3
  • 1 Debre Berhan University, Debre Berhan, Ethiopia
  • 2 Wollo University, Dessie, Amhara, Ethiopia
  • 3 Debre Tabor University, Gondar, Amhara, Ethiopia

The final, formatted version of the article will be published soon.

    Background: This study aimed to evaluate the quality and physicochemical bioequivalence of commercially available brands of hydrochlorothiazide tablets in community pharmacies in Dessie town, Northeast Ethiopia.Experimental-based cross-sectional study design was applied using pharmacopeia and non-pharmacopeia methods. Difference (f1) and similarity (f2) factor values were calculated to assess the in vitro bioequivalence of generic products with the comparator.The study revealed that all investigated brands contain the required active pharmaceutical ingredients. The friability test result was concordant with the United State Pharmacopeia (USP) (<1%) in eight brands, however, brand NF3 (1.36%) failed to pass specification limit. The hardness level of brand NF3 (24.20 N ± 7.32), NF5 (32.19 N ± 4.78), and NF9 (35.02 N ± 3.12) were below the specification limit hardness limit result was concordant (39.23Newton, USP 2019). All generic product weight variation results complied with the USP specification requirement. In the quantitative assay result, the minimum and maximum API (active pharmaceutical ingredient) content were 97.4±0.02 (NF6) and 105.8±0.02 (NF8), respectively API (active pharmaceutical ingredient) which is 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.The majority of sampled brands of hydrochlorothiazide (HCT) tablets met the quality requirements as per USP official test specifications. From similarity factor and difference factor values, all studied brands were equivalent.

    Keywords: Hydrochlorothiazide, in vitro, quality, Weight variation, assay, equivalence

    Received: 12 Mar 2024; Accepted: 17 Jun 2024.

    Copyright: © 2024 Wondmkun, Desta, Ali, Tsige, Linger and Berihun. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Yehualashet T. Wondmkun, Debre Berhan University, Debre Berhan, Ethiopia

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.