Journal of Pharmaceutical Research

Abstract

Objectives : This study focused on the process validation of levofloxacin tablet I. P 500 mg. The objective is to validate the critical process variables to ensure that manufacturing processes consistently produce products of the desired quality. Methods: Validation studies were conducted in three consecutive batches intended for commercial use, making this a concurrent validation study. Process validation was performed according to the approved process validation protocol and the sampling plan. All individual processes, including sifting, dry mixing, granulation, drying, lubrication, compression, coating, and packing, were fully monitored, and the samples were collected according to the sampling plan. The in-process parameters and process variables were checked throughout, ensuring that they remained within the specified limits. Findings : The validation showed that all in-process parameters and process variables were within acceptable limits. No significant deviations or changes in process parameters were observed. The results for individual process validation were as follows: Carr’s index (5-20%), Moisture content (2-3%), Angle of repose (25-30), Thickness (6.0 mm ± 0.1 mm), Hardness (not less than 4 kg/cm²), Average weight (784 mg to 816 mg), Disintegration (not more than 10 minutes), Dissolution (not less than 80% of label claim), Friability (not more than 1% w/w), and Assay (not less than 90% and not more than 110%). All the results were within the specified limits. Novelty : Based on validation data from three consecutive batches, the manufacturing process consistently produces a stable product that meets predetermined specifications and quality attributes. Thus, the method employed in the manufacture of model drugs can be routinely followed with suitable modifications.

Keywords: Carr's Index, Friability, Process Validation, Levofloxacin tablet