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. 2020 Dec 21:12:273-279.
doi: 10.2147/DHPS.S282420. eCollection 2020.

In-vitro Evaluations of Quality Control Parameters of Paracetamol Tablets Marketed in Gondar City, Northwest Ethiopia

Konjit Abebe  1 , Tamirat Bekele Beressa  2 , Bilal Tessema Yimer  1
Affiliations

In-vitro Evaluations of Quality Control Parameters of Paracetamol Tablets Marketed in Gondar City, Northwest Ethiopia

Konjit Abebe et al. Drug Healthc Patient Saf. .

Abstract

Background: The aim of this research was to evaluate quality control parameters of available brands of paracetamol tablets in Gondar city since standard quality parameters are essential for a better quality of the product. The different brands of paracetamol tablets were obtained from local pharmacies in Gondar town and the University of Gondar (UOG) hospital pharmacies.

Methods: Five brands of paracetamol, from each, 102 tablets were collected from private pharmacies, government health centers, and UOG pharmacies. The popular brands in the city, Panadol, Para-denk, Paramol, Paracetamol (EPHARM), and Cadimol, conventional tablets of 500 mg strength were chosen and the tablets were assessed for different quality parameters: weight variation, hardness, friability, disintegration, dissolution, and drug content (assay) using compendial methods. The tablets were evaluated to check if they comply with the specifications of USP (United States Pharmacopeia).

Results: From the results, it was observed that all the brands of paracetamol have passed the tests and met the specifications of USP. Results of weight variation, hardness, friability, and disintegration time ranged from 0.46 to 1.11%, 117.0 to 174.70 N, 0.07 to 0.63%, and 01 to 08 minutes for all the tablets, respectively. The dissolution profiles of all the brands are within the acceptable label claim. The assay results showed that the drug content of the paracetamol brands ranged from 95.04% to 106.81%. The dissolution rate was significantly different (p < 0.05) as compared to code 1 with all brands tested at 30 minutes. The disintegration time of different brands was also significantly different from the comparator (code 1) except code 2.

Conclusion: Based on the finding from this study, there were no significant deviations from pharmacopeia standards and specifications. The brands studied were safe enough and could be used to achieve the desired therapeutic effect.

Keywords: Ethiopia; Gondar; paracetamol; quality control.

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Conflict of interest statement

The authors report no conflicts of interest for this work.

Figures

Figure 1
Figure 1
Calibration curve of assay of paracetamol.
Figure 2
Figure 2
Dissolution profile of five brands of paracetamol tablet in phosphate buffer (5.8).
Figure 3
Figure 3
Disintegration time of paracetamol brands. Code 1 was a comparator; *** indicates p- value < 0.0001.
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