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PROCESS VALIDATION OF CETIRIZINE HYDROCHLORIDE TABLETS

Journal Name:

  • The International Journal of Pharmaceutical Research and Bio-Science

Publication Year:

  • 2013

Key Words:

Author Name
Abstract (2. Language): 
Background and objective: The objective of the study is to form a basis for written Procedures for production and process control which are designed to assure that the drug Cetirizine 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 finished product. So for that purpose a specific method is selected and performed the validation of preferred process. Method: Three consecutive batches of Cetirizine hydrochloride 10 mg tablet manufactured as per the Batch Manufacturing Record. Collected samples at different stages like 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 found within the limits. Results: The results suggest that the all parameters are within the limits. The manufacturing process parameters like sieve integrity, appearance, bulk and tapped density, blend uniformity and assay, all physical parameters like weight variation, hardness and thickness, disintegration time, friability, coating parameters were found within the limits. So the manufacturing process intended for further batches. Conclusions: The process is validated as per specifications. Overall manufacturing processing parameters are analysed and compared with the 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 tablets 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.
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