Analytical Method Development and Validation to Assess the Particle Size Distribution in Azithromycin Oral Suspension 200mg/5ml

Given that it influences the therapeutic product's dissolving profile and bioavailability, particle size is a crucial component of contemporary medication quality. Particle size analysis aids in improving drug quality and improving the pharma product development process. In this research, the particle size distribution of Azithromycin oral suspension is determined using an innovative and accurate approach that was established for the purpose of determining the particle size of the suspension. This approach has produced good, repeatable outcomes. The International Conference on Harmonization's Q2 (R1) guidelines were followed in the development and validation of the wet method, which used water as the dispersant. The results showed that the method was robust and reproducible, with the percentage RSD values found within acceptance limit. The approach presented here in is a precise, verified, and efficacious technique for ascertaining the particle size distribution of oral azithromycin suspension. In-depth discussion of the particle size approach is provided to guarantee comprehension of the particle size distribution and the performance of the method across the product's lifetime.