Process validation of clopidogrel bisulphate 75 mg tablets

摘要

Validation of the individual steps of the processes is called the process validation. In this study the process validation was carried out for the tablet dosage form which contains Clopidogrel bisulphate 75 mg. In tablet dosage form, critical parameters like dry mixing, drying, lubrication and compression were taken up for validation studies. In -process quality monitoring of all critical processing steps was done for three production batches. Assay after lubrication was within the specified limit, indicating blend uniformity. Physical parameters such as weight variation, Thickness, hardness test, friability, disintegration time and assay were checked and results found within the acceptance criteria. During packing operation, strips were checked and found satisfactory. Thus process validation of Clopidogrel bisulphate 75 mg in tablets was successfully completed and found within the specifications.