SPECTROPHOTOMETRIC DETERMINATION AND STABILITY STUDIES OF ARTEMETHER IN ARTEMETHER-LUMEFANTRINE SUSPENSIONS MARKETTED IN ZARIA, NIGERIA, A RESEARCH PROJECT TOPIC ON BIOCHEMISTRY
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=”” 14=”” 98.5-102=”” after=”” ambient=”” analyzing=”” and=”” are=”” artemether=”” be=”” between=”” bottled=”” brands=”” by=”” carried=”” conditions=”” content=”” could=”” days=”” developed=”” different=”” extracting=”” five=”” for=”” from=”” in=”” interchangeably=”” it=”” lumefantrine=”” methanol=”” method.=”” method=”” of=”” out=”” over=”” period=”” powders=”” prepared=”” ranged=”” reconstitution=”” results=”” showed=”” span=”” stability=”” stable=”” standard=”” studies=”” study=”” suggested=”” suspension=”” suspensions=”” table=”” that=”” the=”” this=”” under=”” upto=”” used=”” using=”” was=”” water.=”” with=””>analysis, and that co-formulation of artemether with lumefantrine has no effect on the stability of artemether.
CHAPTER ONE
INTRODUCTION
1.2 General Introduction
Malaria is a public health problem (Loset and Kaur, 2009; Karuna et al., 2014). It is an important cause of morbidity and mortality in children and adults in tropical countries.
About half of the world’s population is at risk of this mosquito borne parasitic disease (WHO, 2010). Malaria is caused by the protozoan parasite Plasmodium and transmitted by mosquitoes (Shah and Patel, 2012). Five species of the parasite have been shown to infect humans: P. falciparum, P. vivax, P. ovale, P. malariae and P. knowlesi. While they share a basic life-cycle, certain distinctive features relate to the virulence of each species. P. falciparum causes the most severe manifestations of malaria including coma, anaemia and multi organ failure. The severity of P. falciparum infection has been attributed to the relatively high parasitemias during infection and to the adherence of P. falciparum infected erythrocytes to the endothelium of capillaries and venules, a process known as sequestration (Dondorp, 2008)
