PROCESS VALIDATION OF CETIRIZINE HYDROCHLORIDE TABLETS

Background and objective: Procedures for production and process control which are designed to ass hydrochloride 10 mg coated tablet have the identity, strength, quality and purity they purport of are represented to possess. It is done by checking and controlling the critical in process parameters and by evaluation of finish ed product. So for that purpose a specific method is selected and performed the validation of preferred process. tablet manufactured as per the Batch Manufacturing Record. Collected sample for sifting, blending, compression and coating as mentioned in the sampling plan for individual process. Then sent for analysis, each parameter is analysed and tested as per specifications and recorded the results, which were fou nd within the limits. within the limits. The manufacturing process parameters like sieve integrity, appearance, bulk and tapped density, blend uniformity and assay, all physical parameters like weigh thickness, disintegration time, friability, coating parameters were found within the limits. So the manufacturing process intended for further batches. specifications. Overall manufactu standard specifications, found within the limit and it was concluded as the parameters mentioned above validated as per BMR and BPR. The process validation data of Cetirizine hydrochloride table reveals that there was no significant variation between batch to batch and all the process variables were studied. Therefore it can be concluded that the process of Cetirizine hydrochloride tablet for the batch size 3 Lac stands Validated.