A comparative evaluation of the pharmaceutical quality of different brands of metformin hydrochloride tablets available in Abuja, Nigeria
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Abstract
Background: Metformin hydrochloride tablets are the most commonly prescribed drug for the management of Type II Diabetes Mellitus. This has resulted in increased importation and manufacturing of various brands of the tablets in Nigeria.
Objective: To evaluate the pharmaceutical quality of different brands of metformin hydrochloride tablets available in Abuja, Nigeria.
Method: Ten brands of metformin hydrochloride tablets were purchased and subjected to pharmaceutical quality evaluations such as friability, hardness, disintegration and dissolution tests. Content of active pharmaceutical ingredient (API) was determined using spectrophotometric analysis as well as reverse phasehigh performance liquid chromatography (RP-HPLC).
Results: All the brands were elegantly labelled, packaged and within their shelf lives. With exception of one brand, they all had NAFDAC registration number. The weight uniformity, friability, hardness and disintegration time values for all the brands were within acceptable limits. Three brands of the products released less than 70 % of their API after 45 min and therefore failed the dissolution test. There was disparity between content assay results using UV spectrophotometry and HPLC. HPLC results showed that only brand failed the test by having 86 % of the API while with UV spectrophotometry; four brands failed the test.
Conclusion: This investigation suggest that four brands of metformin hydrochloride tablets available in Abuja, did not met official specifications even though only one brand was implicated by HPLC analysis. Consequently, this research would recommend continuous sentinel surveillance of metformin tablets and the use of HPLC for product analysis for its high sensitivity and accuracy.
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