Abstract

QUALITY EVALUATION AND COMPARISON OF TEN DIFFERENT BRANDS OF AZITHROMYCIN 500 MG TABLETS, MARKETED IN BARUIPUR, WEST BENGAL, INDIA

Amitesh Chakraborty, Sumana Chatterjee, and Sriparna KunduSen*

ABSTRACT

Azithromycin is an azalide antimicrobial agent that acts by inhibiting protein synthesis in bacteria. Azithromycin is a Schedule H or a prescription drug in India. It is also an essential drug as per World Health Organization. The production of Azithromycin tablets has increased nowadays to meet the increasing demand. Multiple Pharmaceutical companies manufacture Azithromycin tablets of dose 250mg and 500mg. The current study aims to evaluate whether the increase in production has laid any impact on the quality of the products available in the market. Quality evaluation tests of ten different brands of Azithromycin tablets of 500mg manufactured by different companies were performed. The brands were chosen based on market analysis. Quality evaluation of these brands in terms of hardness, thickness, weight variation, friability, diameter, dissolution,drug release and disintegration time were performed following the procedures mentioned in Indian Pharmacopoeia 2018 (I.P 2018). Samples from all the brands passed the organoleptic test, the physical tests like hardness, thickness, friability and diameter. Tablets of all the brands comply with the tests of hardness, thickness, friability, weight variation. All the brands have shown to have an average drug content of more than 90% of the labelled content. Samples from all the brands have shown to disintegrate within 30 minutes and drug release of tablets of all the brands were more than 75% at 45 minutes. All the brands of tablets under study passed the quality control test as per Indian Pharmacopoeia, 2018.

Keywords: Macrolides, Azithromycin, Tablets, Quality Control, Drug release, Assay.