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Assessment of quality control parameters of paracetamol tablet

Student name: Mr Abhishek Kumar Dugar
Guide: Dr Udit Soni
Year of completion: 2018
Host Organisation: Baxil Pharma Private Limited, Uttarakhand
Supervisor (Host Organisation): Mr B.V. Singh
Abstract: Assessment of quality of pharmaceutical products is a prerequisite for provision of safe drugs to consumers. Counterfeit drugs are known to have harmful effects. The study involved evaluating paracetamol 650 mg tablets for its quality on basis of various physical and chemical parameters which are routinely used in the pharmaceutical industry. It was found that paracetamol tablets complied with the tests performed. Assay of sample for amount of drug by UV spectroscopy showed the presence of 100.71% of stated amount of drug which was in consonance as per monograph for paracetamol tablets from IP. Physical parameters such as tablet hardness, length, width & thickness were found to be as per the required specifications of quality. The study also describes various interconnected pathways at which paracetamol act which show that its mechanism of action is resultant of many levels at which paracetamol acts. In addition, the study also highlights regulation of pharmaceutical industry and its framework in India apart from WHO guidelines for GMP. The study also signifies legal framework of regulation as per Drugs and Cosmetics act 1940. QMS as an essential tool for characterizing efficiency and management of production units and consumer acceptance is also highlighted in the report. The report also draws a subtle conclusion about how monographs can be updated if a given parameter can be comparatively studied if other methods are incorporated.

Keywords: Counterfeit, Spectroscopy, Mechanism, Regulation, Monograph