Process Validation of Sitagliptin Film Coated Tablets 100 Mg

Sitagliptin is an antidiabetic medication used to treat type-2 Diabetes Mellitus. As a member of the dipeptidyl peptidase-4 (DPP-4) inhibitor class, Sitagliptin works by inhibiting the enzyme DPP-4, thereby increasing the levels of incretin hormones, which help regulate blood sugar levels. Process validation refers to the documented evidence that ensures the consistency and reliability of a manufacturing process that produces a product meeting predetermined specifications and quality attributes. The primary aim of process validation is to ensure the consistency, safety, effectiveness, and reliability of pharmaceutical products. This project is about the process validation of Sitagliptin film-coated tablets 100 mg, ensuring that the manufacturing process consistently produces a product of the highest quality, in compliance with regulatory requirements, and in line with industry standards. By assessing key process parameters, critical quality attributes, and validation stages, the thesis aims to contribute to the optimization and standardization of the production process for Sitagliptin film-coated tablets.