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)
Summary
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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