ABSTRACT
Background: Metformin Hydrochloride is of the biguanide class and it is the most commonly used drug for the treatment of type II Diabetes Mellitus hence the availability of numerous generic versions or brands of metformin hydrochloride tablets in Nigeria and the world at large.
Aim: To evaluate the pharmaceutical quality of some brands of metformin tablets dispensed in Edo and Delta state.
Method: The pharmaceutical quality of ten different brands of metformin hydrochloride tablets was assessed using tests for weight uniformity, friability, hardness, disintegration, and dissolution. Ultra Violet spectrophotometric analysis was used to determine the active pharmaceutical ingredient (API) content.
Results: All of the brands had good packaging, labels, and were within their shelf lives. All the brands except three, were coated. For weight uniformity and Hardness tests, only two brands were within official limits while for friability test, all the brands were within official limits except one. The disintegration time for all the brands were within acceptable limits. At 30 minutes, only three brands released less than 70% of active content one of which is a sustained release drug and so expected. The active pharmaceutical ingredient content for metformin should be between 95 -105% and three brands from the result were below the lower limit.
Conclusion: Out of the Ten brands involved in this study that are been dispensed in Edo and Delta state, seven of the brands had Satisfactory pharmaceutical quality from spectrophotometric study. The findings emphasize the need for routine adequate surveillance of available brands of metformin and other drugs.
