Validated Analytical Approach for Particle Size Distribution Measurement in Acyclovir Oral Suspension Using Laser Diffraction

Abstract

Particle size analysis is crucial for guaranteeing the quality and functionality of oral suspensions since it has a substantial impact on the dissolving profile and bioavailability of medicinal formulations. The current study used a laser diffraction particle size analyser to design and validate a straightforward, accurate, precise, and reliable Analytical technique for figuring out the particle size distribution in a 200 mg/5 mL oral solution of acyclovir. A Malvern Mastersizer 3000 fitted with a Hydro MV dispersion unit was used to examine the method, which was created utilising the wet dispersion approach using water as the dispersant. The developed technique was validated using the International Conference on Harmonisation (ICH) Q2(R1) standards for factors like method precision, intermediate precision, and robustness. Following the assessment of the Dv(10), Dv(50), and Dv(90) particle size distribution parameters, the obtained percentage of Relative Standard Deviation (%RSD) values were determined to be within acceptable bounds, indicating satisfactory repeatability and reproducibility of the approach. There was no discernible effect on the analytical performance in robustness tests conducted with different stirring speeds and obscuration settings. It was discovered that the established approach was robust, dependable, and appropriate for finding the acyclovir oral suspension's particle size distribution on a regular basis. Thus, quality control and formulation development studies of acyclovir oral suspension products can be successfully conducted using the established analytical approach.