CONCURRENT PROCESS VALIDATION OF GLIBENCLAMIDE 2.5 MG TABLETAbstract
The present study of concurrent process validation delivers an extraordinary degree of quality assurance that a specific process for manufacturing of Glibenclamide Tablets will consistently manufacture a product that meets its predetermined quality attributes and specifications. Glibenclamide is generally suggested for the treatment of type II diabetes mellitus and it is mainly a sulfonylurea derivative. It mainly comprises the stages to be followed to evaluate and qualify the acceptability of the manufacturing process of Glibenclamide 2.5 mg tablets. The process is limited to the three batches H, I, and J manufactured of specific batch size with the help of specified equipment’s and different quality control parameters for tablets. It involves all parameters related to each step were evaluated by the respective standard test involved in the manufacturing. All analytical results of each stage were found to be within the acceptable limit and criteria. Other tests related to compression such as hardness, thickness, disintegration and dissolution for all three batches were also found within the acceptable limit.
Prashant B. Patil, Vilas L. Badgujar, Rajendra D. Wagh and Kundan H. Deore *
NES’s Gangamai College of Pharmacy, Nagaon, Dhule - 424005, Maharashtra, India.
23 October 2020
11 February 2021
23 June 2021
01 October 2021