Neha Sawant, Jawed Akhtar, Stavan Master
Neha Sawant1*, Jawed Akhtar1 and Stavan Master2
1Department of Quality Assurance, Parul Institute of Pharmacy and Research, Affiliated to Gujarat Technological University, Limda, Ta. Waghodia. Dist. Vadodara – 391760, Gujarat, India.
2Department of Quality Assurance, Osaka Pharmaceuticals Pvt. Ltd. Sakarada, Gujarat, India.
Volume - 6,
Issue - 7,
Year - 2013
The purpose of research investigation was to conduct con-current process validation of Metformin Hydrochloride 500 mg tablet dosage form. Quality cannot be merely assured by in-process and finished product testing but it should be built in the manufacturing process by controlling critical parameters which in turn produces product meeting predetermined specifications and quality attributes. For con-current validation three consecutive batches were selected. All instruments required to carry out con-current validation were calibrated as per SOPs. All raw materials used in the manufacturing of the product were verified for the release status. Tablet was manufactured by wet granulation method. Granulation was excellent at 15 minutes because SD was between 0.0058-0.0321.Drying was excellent at 25 minutes because %LOD was less than 3% and bulk Density was within 0.7-0.9 gm/cc. Blending was excellent at 25 minutes because SD was 0.0058-0.3828. For compression parameters like Average weight, Weight of 20 tablets, Hardness, Thickness, Diameter, Friability and Assay were according to specification. For Coating parameters like Average weight, Hardness, Friability, Thickness, Diameter, Dissolution and Assay were as per specifications. All parameters at various stages of tablet manufacturing were as per specifications, so the process was validated properly.
Cite this article:
Neha Sawant, Jawed Akhtar, Stavan Master. Studies in Con-Current Process Validation of Metformin Hydrochloride Tablet Dosage Form. Research J. Pharm. and Tech 6(7): July 2013; Page 718-725.