Kullayappa C*, Naresh G, Muneer S, Hindustan Abdul Ahad
Department of Pharmaceutics, Balaji College of Pharmacy, Ananthapuramu, AP, India
Quality is the primordial intention for process validation is the means of ensuring and providing documentary evidence that processes within their specified design parameters are capable of repeatedly and reliably producing a finished product of required quality. In this study process validation is carried out for tablet dosage form Terbinafine Hydrochloride. The process validation of Terbinafine HCl Tablets of dose 250 mg was carried out for three consecutive batches of BN – 1, BN – 2, and BN – 3 which includes the validation of critical steps of manufacturing constituting Dispensing, Sifting, Dry mixing, Granulation, Drying, Blending and Compression. Dissolution profile of the three consecutive validation batches viz., BN-1, BN – 2 and BN – 3 were compared with the reference sample (XYZ). All the above mentioned processes have been validated during the process validation. The results obtained for the three validation batches viz., BN-1, BN-2 and BN-3 were found to be within the limits. Therefore, the product with required specifications can be consistently obtained.
Keywords: Terbinafine Hydrochloride, Quality, Process validation, blending.