The Physicochemical Equivalence of Eight Brands of Amlodipine Tablets in Lagos, Nigeria
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Date
2012-09
Authors
Olayemi, S.O.
Akinleye, M.O.
Awodele, E.O.
Idris, O.
Oladimeji-salami, J.
Journal Title
Journal ISSN
Volume Title
Publisher
West college of medicine
Abstract
BACKGROUND: Amlodipine is a dihydropyridine calcium channel antagonist that is useful in the treatment of hypertension and angina pectoris. In addition to the innovator brand of this molecule, several generic brands are marketed in Nigeria.
OBJECTIVE: To evaluate the physicochemical equivalence of eight brands of amlodipine tablets marketed in Lagos, Nigeria.
METHODS: Physicochemical properties such as identity, weight uniformity, friability, hardness test, disintegration test, dissolution test and assay of active ingredients were performed using the methods described in the British and the United States Pharmacopoeia.
Ultra-violetspectrophotometric and High performance liquid chromatographic methods were used
for assay of the labelled amount of amlodipine in the products.
RESULTS: All the products passed weight uniformity and disintegration tests. Only one brand failed the friability test. Two brands had mean crushing strength less than 4kg/cm2; while only 4 brands passed dissolution test by releasing >75% of the labelled amlodipine within 45 minutes. One brand failed both assay and dissolution tests by returning less than official specifications in the general monograph for conventional tablets. In all, four of the eight sample products analyzed
passed all the tests. These can be said to be physicochemically equivalent and may be clinically interchangeable or substituted.
CONCLUSION: This study further highlights the concerns over the quality of drug products marketed in a developing country.
Description
Staff publications
Keywords
Physicochemical , equivalence , amlodipine, , tablets , Research Subject Categories::NATURAL SCIENCES::Chemistry
Citation
Olayemi, S.O [Et...al]. (2012). The Physicochemical Equivalence of Eight Brands of Amlodipine Tablets in Lagos, Nigeria. West African Journal of Medicine Vol. 31(3).