Prospective Process Validation Study of Glibenclamide 2.5 mg Tablets

Prashant B Patil; Vivekanand K Chatap; Mahesh P More; Zamir G Khan

doi:10.24092/CRPS.2018.080201

Prashant B Patil Department of Pharmacy, H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist: Dhule (MS)- 425 405 India
Vivekanand K Chatap Department of Pharmacy, H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist: Dhule (MS)- 425 405 India
Mahesh P More Department of Pharmacy, H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist: Dhule (MS)- 425 405 India
Zamir G Khan Department of Pharmaceutical Chemistry, H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist: Dhule (MS)- 425 405 India

DOI https://doi.org/10.24092/CRPS.2018.080201

Abstract

The present study provides a high degree of assurance that a specific process for manufacturing of Glibenclamide Tablets will consistently produce a product meeting its predetermined quality attributes and specifications. It mainly comprises the stages to be followed to evaluate and qualify the acceptability of manufacturing process of Glibenclamide 2.5 mg tablets. The process is limited to the three batches manufactured of specific batch size with specified equipments and control parameters for tablets. It involves All parameters related to the each step were evaluated by respective standard test involved in the manufacturing. Sampling, testing plan and acceptance criteria for each step were monitored. The analytical results of all stages were found to be within the acceptable limit. Other tests related to compression such as hardness, thickness, disintegration and dissolution for all three batches were found within the acceptable limit.

Keywords: Glibenclamide, Blend Uniformity, Assay of Glibenclamide, Process Validation of Glibenclamide, Glibenclamide tablets

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