An Ultraviolet-Visible (UV-vis) Spectrophotometric Determination of Pharmaceutical Equivalence of Some Enalapril Maleate Tablet Generics Marketed in Nigeria

Abstract Anultraviolet-visible (UV-vis) spectrophotometric determination of enalapril maleate content and other biopharmaceutical parameters using five tablet generics of the drug marketed in Nigeria were conducted to access the quality and compliance of these commercial brands with pharmacopeia standard. The quality of the brands were evaluated using methods described in USP and BP which included, weight uniformity test, dissolution test, disintegration test, friability test and hardness test. Content of active ingredient was evaluated by means of the UV/Vis spectrophotometer at 240 nm. Beer Lambert’s law was obeyed over the concentration of 10-60 g/mL with a correlation coefficient (R2) of 0.984. The different brands used complied with the standard specifications for the weight uniformity, disintegration, dissolution and content of active ingredient tests. Only three of the brands passed the friability and hardness tests. The in vitro bioequivalent results, however, showed that only two brands (ENP-2 and ENP-3) could be considered bioequivalent and interchangeable with the innovator brand (ENP-5), while ENP-1 and ENP-4 should be subjected to constant drug monitoring and pharmacovigilance when prescribed in place of the innovator brand.

Keywords Quality Assessment, Innovator Brand, Enalapril maleate, Tablets, Nigeria, UV.

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Updated: January 20, 2024 — 8:48 am