Physico-chemical evaluation of four brands of Paracetamol 500mg tablets by using quality control techniques

Abstract Paracetamol is common non-steroidal anti-inflammatory drug (NSAID) and it is over-the counter (OTC) drug, frequently used as analgesic, antipyretic and against different aches. The purpose of this research work is to assess the quality of four brands of Paracetamol tablets by using different test parameters Greater Noida, India. Four brands of Paracetamol 500mg tablets were analyzed by different Physico-chemical quality evaluation parameters as per Indian Pharmacopeia (IP) standard. Based on the result of the current study, all the brand samples passed hardness, thickness, weight uniformity and friability tests and they satisfy the IP standard limit. All test samples are disintegrated in distilled water within the range between 3.17 to 7.75 min. This indicates the disintegration rate of all the samples are less than 15min.Moreover the dissolution test confirmed that the percentage drug release of the three study brands of Paracetamol at 30 minutes were was over 80% in conformity with the Pharmacopeia specification limit and one brand sample fail to IP specification limit. The drug assay results of the test samples were determined by UV spectrophotometer analytic technique. The percentage drug content results of the samples by UV technique are ranged between 90.8% and 104.6%. It was observed that out of four brands samples, three samples (P1, P3 and P4) comply with Pharmacopeia specification limit (95-105%). In general, the results of this study show that most of the brand samples satisfy all quality control parameters with low standard deviations.

Keywords Over- the- counter, quality control parameter, Paracetamol, Pharmacopeia.

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Updated: January 20, 2024 — 8:11 am