Dissolution Profile of Dosage forms of ACT Anti-Malarial Drugs from North-Central Part of Nigeria

Aims/Objective: To examine the rate and percentage release of the active constituents of brands of ACT anti-malarial drugs using UV-Visible Spectrophotometric method to ascertain its applicability in quality control of ACTs for effective treatment.
Place and Duration of Study: The study was carried-out on the North-central part of Nigeria between the March, 2013 and July 2013.
Methodology: In vitro release of artemether and lumefantrine from tablets dosage form was evaluated one after the other. The methods comprised of dissolution medium of 900 ml distilled water (for artemether) and 1000 ml of 0.1 M HCl (for lumefantrine) per vessel with the paddle rotating at 100 rpm for 60 minutes (artemether) and 45 minutes (lumefantrine) at the temperature of 36°C to 37°C.The dissolved samples were analyzed using UV-Visible spectrophotometer at 216 nm (artemether) and 302 nm (lumefantrine) after method validation for accuracy, precision, linearity and specificity.
Results: The outcome of the study indicated the best release time for artemether from 2-10 minutes and 10 - 30 minutes for lumefantrine with 88% of the samples complied with USP specified requirement for dissolution test. The statistical P-value (P < 0.05) of mean (0.1007) and variance (0.7533) for artemether released were non-significant, while for lumefantrine, mean (0.0130) and variance (0.0446) were significant among the samples.
Conclusion: This method indicated that, UV-Visible spectrophotometric method could be used as non-simultaneous in vitro dissolution test for artemether and lumefantrine in tablet dosage combination forms. The method is simple, fast and cost-effective therefore it can be adopted for continual periodic monitoring of drug quality in order to sustain survival of quality drugs for malaria treatment among the populace.