ABSTRACT

Atorvastatin is a lipid-lowering drug included in the statin class of medications. By inhibiting the endogenous production of cholesterol in the liver, statins lower abnormal cholesterol and lipid levels, and ultimately reduce the risk of cardiovascular disease. The present research work focused on formulation and concurrent process validation for Atorvastatin calcium 40 mg tablets. By wet granulation method the tablets are manufactured. Validation is an integral part of quality assurance; it involves systematically studying systems, facilities and processes to determine whether they perform their intended functions adequately and consistently as specified. This study took three batch of Atorvastatin tablets with same size, method, equipment & validation criteria. As part of the validation protocol, various critical parameters were identified and evaluated during dry mixing, wet granulation, drying, lubrication, compression, and coating stages. Throughout the process, process validation data provided high degrees of assurance that the manufacturing process would produce a product with the predetermined quality attributes that were given. This study concludes that the wet granulation method is effective in ensuring uniform distribution of Atorvastatin and reproducible quality standards in manufacturing tablets. Keywords: Validation, Atorvastatin, Compression, Wet granulation
Publication date: 01/10/2025

https://ijbpas.com/pdf/2025/October/MS_IJBPAS_2025_9501.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.10.9501