Abstract:

Background; Azithromycin is a semi synthetic azalide macrolide with bacteriostatic activity that acts by inhibits bacterial protein biosynthesis by binding irreversibly to the 50s ribosomal subunit. It is used in the treatment of respiratory, gastrointestinal, skin and sexually transmitted infections. Different azithromycin tablet brands available on market should be of good quality to ensure the drugs are chemically and pharmaceutically equivalent in strength, quality, purity, active ingredient and release profile.

Method: The study was a quality control laboratory based analytical study conducted at TMDA laboratories which involved eighty (80) tablets, twenty from each of the four samples.

Results: Four brands analysed were ZAHA, AZIBIAL, ZOLTRIM and AZUMA. In the identification test, the retention times of samples were (4.77, 4.76, 4.79 and 4.83) minutes and that of the reference standard was 4.77 minutes and in the assay test the values were 101.5%, 102.06%, 100.07% and 98.85% respectively.

Discussion/conclusion: All the four samples (100%) passed the assay test as their values were within the USP limit of assay (90%-110%). Also all the samples (100%) passed the identification test as their retention times (4.77-4.83 minutes) were approximately similar to the retention time to reference standard (4.77minutes) therefore all azithromycin tablet brands tested were of good quality and can be used for treatment purposes.