Process Validation of Amoxicillin and Clavulanic Acid Immediate Release Tablets by Wet Granulation Method

The current aim is to study and validate the manufacturing process of amoxicillin trihydrate and potassium clavulanate tablets immediate release tablets. Amoxicillin trihydrate and potassium clavulanate are antibiotic and bet- lactimase inhibitor used in the treatment of pharyngitis/tonsillitis, respiratory tract infections and some microbial infections. The present work was undertaken with a goal to carry out a study on concurrent process validation of antibiotic solid dosage forms for three consecutive batches to prove that system remains in control and the process is capable of consistently produce tablets meeting the predetermined process variables, acceptance criteria and quality attributes. Based on the results of the validation data for three consecutive batches, it is concluded that the manufacturing process used for Amoxicillin Trihydrate and Potassium Clavulanate Immediate Release tablets 625 mg consistently producing the stable product meeting its predetermined specifications and quality attributes. Hence the method employed in the manufacture of Amoxicillin Trihydrate and Potassium Clavulanate immediate release tablets is considered to be validated and can be routinely followed.