PROCESS VALIDATION OF LOPERAMIDE HCl TABLET

Abstract

ABSTRACT To survive in competitive market and to be successful, it is necessary to achieve high level of product quality. Loperamide HCl [4-(P-chlorophenyl)-4-hydroxy-N,N-dimethyldiphenyl-1-piperidine butyramide hydrochloride), is an opiate agonist widely used as an effective drug for the control and relief of acute diarrhoea. Loperamide HCl tablets were prepared by wet granulation method. After process validation, it has been found that the prepared tablets showed good physical characteristics, drug content and all parameters were within the limits. Hence, it can be recommended that, the same parameters shall be considered as final for further commercial routine production batches of Loperamide HCl tablets