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Research Article Open access CC BY 4.0

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

Amit Gosar, Shivaji Folane, Sanjay Pawar, Mithun Gharat, Amit Lalge, Shivaji Jadhav

Journal of Pharmaceutical Research International · pp. 1–9 · Published 5 Jul 2017

10.9734/JPRI/2017/33911

Abstract

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.

Metformin hydrochloride method development method validation particle size analyzer (PSA)

Cited by 1

Design and in vitro characterization of novel pulsatile delivery system of biguanide antidiabetic drug

Rahul Pandey, William Selvamurthy · Journal of Pharmacy And Bioallied Sciences · 2020

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