Sheila H Mambea CUHAS/BP/3000545/T/18

Quality of different brands of Azithromycin tablets available in Nyamagana pharmacies in Mwanza, Tanzania - Mwanza, Tanzania: Catholic University of Health and Allied Sciences [CUHAS – Bugando] ©08.09.2022 - Pages ix; 23 Includes References and Appendices

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.


= OPERATIONAL DEFINITIONS Assay test Is an investigative procedure for quantitative measuring of amount of active ingredients in a given sample OPERATIONAL DEFINITIONS Falsified drug A drug that does not contain active ingredient or contain wrong active ingredient OPERATIONAL DEFINITIONS Quality drug Azithromycin tablet that has an active ingredient within the range of 90%-110% OPERATIONAL DEFINITIONS Substandard drug A drug whose amount of active ingredient is less than 90% or more than 110% = ABBREVIATIONS API Active Pharmaceutical Ingredient HPLC High Performance Liquid Chromatography TMDA Tanzania Medicine and Medical Devices Authority USP United States pharmacopoeia WHO World Health Organization

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