Abstract
Particle size is a key factor for modern drug quality since it affects the bioavailability and dissolution profile of the drug product. Study for Particle size is helpful to optimize drug product development process and improve the quality of drugs. In Order to determine the particle size of Glimepiride a novel and accurate Particle size determination method has been developed for the determination of particle size distribution of Glimepiride was described in this paper. This method has shown good reproducible results. By using water as dispersant wet method is developed and validated as per International conference on Harmonization guidelines (Q2 (R1)) 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 Glimepiride. Particle size method is discussed in detail to ensure in-depth understanding of particle size distribution and particle size method performance during lifetime of the product.
Highlights
Glimepiride is a white to yellowish-white, odorless powder and is practically insoluble in water
In Order to determine the particle size of Glimepiride a novel and accurate Particle size determination method has been developed for the determination of particle size distribution of Glimepiride was described in this paper
Glimepiride chemically, is 3-ethyl-4methyl-N-[2-[4-[(4-methylcyclohexyl)carbamoyllsulfamoyl] phenyl] ethyl]-2-oxo-5H-pyrrole-1-carboxamide is a third generation sulfonylurea derivative which is commonly used in the treatment of non-insulin dependent Type 2 diabetes mellitus [2,3,4,5]
Summary
Glimepiride is a white to yellowish-white, odorless powder and is practically insoluble in water. Glimepiride chemically, is 3-ethyl-4methyl-N-[2-[4-[(4-methylcyclohexyl)carbamoyllsulfamoyl] phenyl] ethyl]-2-oxo-5H-pyrrole-1-carboxamide is a third generation sulfonylurea derivative which is commonly used in the treatment of non-insulin dependent Type 2 diabetes mellitus [2,3,4,5]. Glimepiride, marked under the trade name Amaryl, is the first line medication for the treatment of type-2 diabetes mellitus [6,7,8]. Literature survey done for Particle size distribution method for Glimepiride and found that particle size determination method is not available. Study was carried out to develop a method to determine particle size distribution of Glimepiride by Particle size analyzer and further validation of the method, was carried out
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