PHARMACEUTICAL QUALITY ASSESSMENT OF BRANDS OF METFORMIN HYDROCHLORIDE TABLETS AVAILABLE IN SOUTH-EAST NIGERIA
|ERAGA SYLVESTER OKHUELEGBE1,*, IDEMILI CHIDOZIE AUGUSTINE DENNIS2, IWUAGWU MAGNUS AMARA2|
Afr. J Pharm Res Dev; Volume 12(3): 333-341 (2020)
Nigerian pharmaceutical market is replicate with various imported brands of metformin tablets. The aim of the study was to assess the quality of different brands of metformin hydrochloride tablets available in the south-east zone of Nigeria. Fifteen (15) brands of metformin hydrochloride tablets were bought and evaluated for tablet weight, dimensions, friability, crushing strength, disintegration time and dissolution profiles. Content of active pharmaceutical ingredient (API) of the different brands was determined using spectrophotometric analysis. Twelve brands of the tablets were immediate release, two were slow release and one was an extended release dosage form. They were within their shelf lives, well labelled and packaged, and only two brands were not registered by the National Agency for Food and Drug Administration and Control (NAFDAC). There were significant variations (p < 0.05) in the weight, friability, hardness and disintegration times among the brands but not within the brands. The crushing strength and friability values of some brands were not within acceptable official limits. Three (3) immediate release brands released less than 70% of metformin within 45 min. All the brands met the official specifications of 95-105% drug content in the content assay results. The brands of metformin hydrochloride (500 mg tablets) exhibited variations in their tablet parameters. Three brands failed the dissolution test and all the brands had acceptable content of API. These results highlight the need to routinely carry out market surveillance of pharmaceutical drug products to ensure access to quality and efficacious drugs.
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KEYWORDS: Metformin hydrochloride; Tablets properties; Pharmaceutical quality; Assay.