SPECTROPHOTOMETRIC DETERMINATION AND STABILITY STUDIES OF ARTEMETHER IN ARTEMETHER-LUMEFANTRINE SUSPENSIONS MARKETTED IN NIGERIA
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ABSTRACT
The increasing use of artemether-lumefantrine combination as an effective treatment for resistant malaria demands the need for analytical methods for the quality control of these drugs in tablets and suspensions. Though some UV Spectrophotometric methods have been developed for quantification of artemether in various biological fluids and formulations, they require strainous heating conditions which is a limitation. This limitation coupled with non-availability of HPLC hence the need to develop and validate a simple method for the quantification of artemether in peadiatric suspensions. In this work, we report the method developed by reacting artemether solution in methanol with concentrated HCl for 30 minutes to obtain an α,β-unsaturated ketone which was scanned with a UV Spectrophotometer. The method developed obeyed Beers law in the range 20 – 120 µg/ml, slope (y); 0.01 0, intercept (x) 0.193, correlation coefficient (r) 0.9987, λmax 260 nm, precision (% CV); 2, Accuracy (% Er); 2.67 and a recovery of 97%. The detection and quantification Limit (µg/ml) are 0.14 and 0.58 respectively. The developed method was successfully applied in the assay of five brands of artemether-lumefantrine suspensions with 98-101.6% content, and comparism of the means of the assay results of the method and the IP (2008) method showed no statistically significant difference (P<0.05). Stability studies of the standard artemether suspension prepared and five different brands of artemether/lumefantrine powders for suspension was carried out by extracting artemether with methanol from the suspensions and analyzing it using the developed method. The content of artemether over 14 days study period ranged between 98.5-102% and this showed that the suspensions are stable under ambient conditions for upto 14 days after reconstitution with bottled table water. The results of the study suggested that the developed method could be used interchangeably in viii analysis, and that co-formulation of artemether with lumefantrine has no effect on the stability of artemether.
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