Quality Control and Stability Studies of Some Selected Brands of Metronidazole Tablets Marketed in Daura Katsina State, Nigeria

Sani Sa’idu Bello and Mustapha Muazu

Department of Pharmaceutical and Medicinal Chemistry, Bayero University, Kano, Nigeria

*Corresponding author’s Email: ssbello.phc@buk.edu.ng, doi.org/10.55639/607.02010015


ABSTRACT

Multi-source pharmaceutical products are intended to be pharmaceutically equivalent or pharmaceutical alternatives if they are bioequivalent and hence can be therapeutically equivalent and interchangeable. Thus, the need to asses’ different brands of the same generic to ensure the quality of these brands to achieve the same pharmacological value is necessary. Therefore, seven (7) brandsof Metronidazole (200 mg) tablets marketed in Daura, Katsina State, Nigeria were selected randomly for the study. Quality control parameters and stability studies were conducted on these brands which include, identification test, weight variation test and friability test by official method. UV Spectrophotometric method was used to test for the assay of the selected brands. The presence of Metronidazole was observed in all the samples. The Assay percentages of the selected brands are in the range of 97.08 – 98.29 %. Weight variation are within acceptable limit except KK 5. The friability value of samples KK1, KK2 and KK7 showed acceptable levels of 1 % while KK 3, KK 4, KK 5 and KK 6 have values of 1.97 %, 5.30 %, 3.90 % and 100 % respectively. The stability of the samples at 0oC, 25oC, and 37.5oC showed insignificant change in the percentage content. However, at 50ºC and 60ºC a significant decrease in percentage content was observed. The samples of the Metronidazole 200 mg tablets analysed can be used interchangeably even though there was some variation in some of their pharmaceutical equivalences and storage temperature of Metronidazole tablets can be in the range of 25ºC – 37.5o

Keywords:

Metronidazole,
UV
Spectrophotometry,
Stability,
Assay