Comparative Quality Evaluation of Marketed Cefixime Trihydrate Tablet Brands Available in Bangladesh
- 1Department of Pharmaceutical Sciences School of Health & Life Sciences North South University Dhaka Bangladesh northsouth.edu
Abstract
Aims: In low‐ and middle‐income countries, antibiotic resistance is rising rapidly because of poor medication adherence, polypharmacy, and weak regulatory enforcement, while substandard and counterfeit medicines further accelerate resistance. Cefixime trihydrate, a broad‐spectrum third‐generation cephalosporin, is a widely used and frequently prescribed antibiotic in Bangladesh. This study evaluated quality attributes, including % drug content and % drug release, of eight commonly prescribed cefixime 200 mg tablet brands and compared them with the innovator‐equivalent brand.
Methods: Chromatographic separation was performed on a reversed‐phase C18 column with UV detection at 282 nm (column temperature 30°C; run time 8 min), using methanol and 0.01 M KH2PO4 buffer (pH 4.5) at 1 mL/min. Dissolution studies were conducted using a USP Apparatus 2, and antimicrobial activity was assessed via the Kirby–Bauer disc diffusion method.
Results: All nine brands met USP potency standards (90%–110%) and dissolution criteria (≥ 75% drug release within 45 min). A one‐way ANOVA with Dunnett′s test (α = 0.05, two‐tailed; critical value = 2.731) revealed significant differences between Tab. A, Tab. E, and Tab. F and the reference brand at 45 min. However, among local brands, seven out of eight (87.5%) complied with the FDA‐recommended difference factor (f1) and similarity (f2) factor criteria. Zone of inhibition studies showed good antimicrobial activity across most of the brands at 5 μg disc load.
Conclusion: Seven out of the eight local brands met the f1/f2 similarity criteria relative to the reference, indicating comparable in vitro dissolution behavior, whereas one brand (Tab. C) did not. These results emphasize the need for continuous quality surveillance to ensure therapeutic equivalence and combat antimicrobial resistance.
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BibTeX
@article{islam2026comparative,
title = {{Comparative Quality Evaluation of Marketed Cefixime Trihydrate Tablet Brands Available in Bangladesh}},
author = {Ariful Islam and Shahriar Alam Shanto and Sumaiya Akter and Antara Nashrah and Mashiwat Mahboub and Zannatul Ferdous Fariha and Afia Anjum and Ferdous Khan and Md Hasanuzzaman Shohag},
journal = {The Scientific World Journal},
year = {2026},
month = oct,
doi = {10.1155/tswj/4894162},
url = {https://doi.org/10.1155/tswj/4894162},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Comparative Quality Evaluation of Marketed Cefixime Trihydrate Tablet Brands Available in Bangladesh
AU - Ariful Islam
AU - Shahriar Alam Shanto
AU - Sumaiya Akter
AU - Antara Nashrah
AU - Mashiwat Mahboub
AU - Zannatul Ferdous Fariha
AU - Afia Anjum
AU - Ferdous Khan
AU - Md Hasanuzzaman Shohag
PY - 2026
DA - 2026/10/26
JO - The Scientific World Journal
DO - 10.1155/tswj/4894162
UR - https://doi.org/10.1155/tswj/4894162
AB - Aims: In low‐ and middle‐income countries, antibiotic resistance is rising rapidly because of poor medication adherence, polypharmacy, and weak regulatory enforcement, while substandard and counterfeit medicines further accelerate resistance. Cefixime trihydrate, a broad‐spectrum third‐generation cephalosporin, is a widely used and frequently prescribed antibiotic in Bangladesh. This study evaluated quality attributes, including % drug content and % drug release, of eight commonly prescribed cefixime 200 mg tablet brands and compared them with the innovator‐equivalent brand. Methods: Chromatographic separation was performed on a reversed‐phase C18 column with UV detection at 282 nm (column temperature 30°C; run time 8 min), using methanol and 0.01 M KH2PO4 buffer (pH 4.5) at 1 mL/min. Dissolution studies were conducted using a USP Apparatus 2, and antimicrobial activity was assessed via the Kirby–Bauer disc diffusion method. Results: All nine brands met USP potency standards (90%–110%) and dissolution criteria (≥ 75% drug release within 45 min). A one‐way ANOVA with Dunnett′s test (α = 0.05, two‐tailed; critical value = 2.731) revealed significant differences between Tab. A, Tab. E, and Tab. F and the reference brand at 45 min. However, among local brands, seven out of eight (87.5%) complied with the FDA‐recommended difference factor (f1) and similarity (f2) factor criteria. Zone of inhibition studies showed good antimicrobial activity across most of the brands at 5 μg disc load. Conclusion: Seven out of the eight local brands met the f1/f2 similarity criteria relative to the reference, indicating comparable in vitro dissolution behavior, whereas one brand (Tab. C) did not. These results emphasize the need for continuous quality surveillance to ensure therapeutic equivalence and combat antimicrobial resistance.
SN - 2356-6140
SN - 1537-744X
ER -