Abstract

Model-Based Bioequivalence assessment of a commercial Azithromycin Capsule against Pfizer Zithromax® Tablet marketed in JamaicaAmusa S. Adebayo and Noel McFarlane

Highlights

  • Azithromycin (AZM), (Fig 1) (USP, 2015), is a semisynthetic 15-membered macrolide antibiotic

  • The linearity was observed over the concentration range of 5–200 μg mL-1 (R2 > 0.9999).The limit of detection (LOD) and limit of quantification (LOQ) were 0.476 μg mL-1 and 1.443 μgmL-1 respectively. the developed method was statistically confirmed to be accurate, precise, and reproducible

  • The alkaline nature of AZM has made it absorbed by the silanol group (Si–OH) on the silica surface of the chromatographic packing, which caused a serious tailing of the chromatographic peaks (Chang et al, 2016)

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Summary

Introduction

Azithromycin (AZM), (Fig 1) (USP, 2015), is a semisynthetic 15-membered macrolide antibiotic It is the first azalide subclass among its family members with a superior antibacterial activity in the market for the last three decades. AZM (anhydrous) has a lipophilic nature (log P = 4) with a relatively large molecular weight of 749 g mol-1. It was initially synthesized from erythromycin in an attempt to produce an acid stable macrolide, with a wider bacterial spectrum, and longer half-life (68h) (Imperi et al, 2014). AZM was prepared and quantified in type III oral lipid based formulation, which is named as self-emulsifying drug delivery system (SEDDs)

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