Abstract

PROCESS VALIDATION OF METFORMIN HYDROCHLORIDE AND GLICLAZIDE BILAYER TABLETS

Y. Phani Krishna*, B. Appa Rao, B. V. Narasimha Rao, M. Mary Prasanthi, D. Venkata Ramana

ABSTRACT

The validation is a fundamental segment that supports to a commitment of company towards quality assurance. It also assures that product meets its predetermined quality specification and quality characteristics. Validation of individual step of manufacturing is called as process validation. It is concerns with the process validation of tablet dosage form which has a numerous advantages over other dosage forms. The purpose of research was to study prospective process validation metformin HCL 500mg and gliclazide 60mg tablet dosage formulation. The critical process parameter was identified with the help of process capability and evaluated by challenging its lower & upper release specification. Three initial process validation batches (1, 2 & 3) of same size, method, equipment & validation criteria were taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication & compression stages were identified and evaluated as per validation master plan. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.

Keywords: Metformin HCL, Gliclazide, Process validation and Quality attributes.