PROCESS VALIDATION OF DICLOFENAC SODIUM, PARACETAMOL AND CHLORZOXAZONE TABLETS

Abstract

Validation is a tool of quality assurance which provides confirmation of the quality in equipment systems, manufacturing processes, software and testing methods. Validation of the individual steps of the processes is called the process validation. In this study the process validation was carried out for the combined tablet dosage form which contains Diclofenac sodium 50mg, Paracetamol 325 mg and Chlorzoxazone 250 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, hardness test and friability and assay were checked and results found within the acceptance criteria. During packing operation, blisters were checked and found satisfactory. Thus process validation of Diclofenac sodium 50mg, Paracetamol 325 mg and Chlorzoxazone 250 mg in combined solid dosage form was successfully completed and found within the specifications.