SEARCH FOR ARTICLES

Pharamgene

“Process Validation of Diazepam in Pharmaceutical Dosage Form”
Keyur Ajudiya *1 , Dipal Parmar 1

1Parul Institute of Pharmacy and Research

Abstract
The purpose of this research was to study the Concurrent process validation of Diazepam in pharmaceutical dosage form. For Concurrent process validation, three batches were taken into consideration.All the instruments were calibrated as per standard operating procedures. The critical parameter involved in the process like sifting, mixing, granulation, drying, lubrication, compression were identified and evaluated. Uniformity of blend result, Assay of drug in tablet, Uniformity of dosage unit and Dissolutionstudywereacceptable.Theoutcomeindicatesthatthisprocessvalidationdataprovideshighdegreeofassurancethat manufacturing process produces product meeting its predetermined specifications and quality attributes. So, manufacturing processofDiazepamtabletisconsideredasvalidated.

[Full Text PDF]