QUALITY CONTROL ASSESSMENT ON THREE DIFFERENT BRANDS OF AZITHROMYCIN 500MG TABLETS
Abstract
Azithromycin is a widely prescribed broad-spectrum macrolide antibiotic used in
the treatment of respiratory, skin, and sexually transmitted infections. The
availability of multiple generic brands in the pharmaceutical market, particularly in
developing countries, raises concerns about the quality and therapeutic equivalence
of these products. This study aimed to evaluate the quality of three commercially
available brands of azithromycin 500 mg tablets marketed in Nigeria using
pharmacopeial quality control parameters. Three brands, coded as A, B, and C,
were subjected to physical and in-vitro quality assessment tests in accordance with
United States Pharmacopoeia (USP) and British Pharmacopoeia (BP) standards.
The evaluated parameters included weight variation, friability, hardness,
disintegration time, and dissolution profile. Dissolution testing was carried out
using phosphate buffer (pH 6.0), and drug release was analyzed using a UV-visible
spectrophotometer. Results showed that all three brands complied with
pharmacopeial limits for weight variation, friability (
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