Development and Validation of New Analytical Method for the Determination of Particle Size Distribution of Metformin Hydrochloride Using Laser Based Particle Size Analyzer

摘要

Metformin Hydrochloride has characteristic nature of lump formation and determination of particle size with reproducible result is difficult and particle size determination method is not reported in literature. Hence novel rugged and reproducible method has been developed for the determination of particle size distribution of Metformin Hydrochloride.The wet method using Isopar G as dispersant has been developed and validated as per International conference on Harmonization guidelines (Q2R1) and found out robust and reproducible with % RSD of d(10), d(50) and d(90) values found within acceptance limit ranges from 6.05% to 21.84% for d(0.1), 3.04% to 9.87% for d(0.5) and 4.69% to 14.32% for d(0.9) in validation. The described method is accurate and validated and successfully applied for the determination of particle size distribution of Metformin Hydrochloride.