Process Validation of Extended Release Bi-Layered Tablet Containing Dapagliflozin, Sitagliptin & Metformin Hydrochloride

The Purpose of research was to study process validation for Dapagliflozin 10 mg, Sitagliptin 100 mg, and Metformin Hydrochloride 500 mg (Extended Release) Bilayered Tablets. The critical process parameters were identified with the help of process capability and evaluated by challenging its lower & upper release specifications. Three initial process validation batches (I, II, III) of the same size, method, equipment & validation criteria were taken. The critical parameters involved in sifting, dry mixing, preparation, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication, compression stage & coating were identified and evaluated as per validation master plan. The process indicated that this process validation provides high degree of assurance that manufacturing process produces a product meeting its predetermined specification and quality attributes.