Artemether–Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method

Abstract

Abstract. We developed and validated a new analytical method for the simultaneous quantification of artemether and lumefantrine in fixed-dose tablets and powders for reconstitution into pediatric suspensions (PSs). The method showed linearity (r 2 > 0.9947), precision (coefficient of variation < 2%), accuracy (deviation of mean from actual concentrations < 4%), and specificity (peak purities > 99%). The validated method was used to analyze 24 batches of fixed-dose tablets and PSs of artemether and lumefantrine. Of the samples, 23 were obtained using convenience sampling of commonly available brands within Accra in Ghana and one was obtained from Aarhus University Hospital. In all, 83.3% (confidence interval: 80-120%) passed for both artemether and lumefantrine contents, 16.7% failed by the U.S. Pharmacopoeia standards, 8.3% failed for one content, and 8.3% failed for both contents. All four products (16.7%) that failed were PSs, and two (8.3%) showed higher levels of artemether than prescribed (222% and 756%).

Enhanced oral delivery of artemether: An application of Prosochit®

“…The suitability of Prosochit ® in enhancing oral delivery of artemether is in consonance with the work of Ngwuluka et al (2015) which showed that combination of two polymers is often superior to the individual ingredient. Previous work showed that PRG caused delayed release of artemether but enhanced permeation compared to acacia gum (Olorunsola et al, 2017), whereas dissolution is the rate-limiting step for the absorption of the drug (Rosenthal, 2004).…”

“…Different concentrations of artemether (0.05%, 0.10%, 0.15%, 0.20%, and 0.25% w/v) were prepared in 1.0-mol.l −1 ethanolic hydrochloric acid (International Pharmacopoeia, 2006) and the absorbance was taken at 210 nm (Debra et al, 2016). This was used to get the Beer-Lambert's plot for artemether.…”

“…The low oral bioavailability of artemether (35.0%-43.2%) is due to its poor water-solubility (Laxmi et al, 2015;Tayade and Nagarsenker, 2010). The previous work on the oral delivery of the drug using acacia gum, cashew gum, and prosopis gum (PRG) showed that the PRG caused delayed drug release but enhanced permeation compared to acacia gum, a known standard gum (Olorunsola et al, 2017).…”

Quality Assessment of Some Essential Children’s Medicines Sold in Licensed Outlets in Ashanti Region, Ghana

“…An assessment of the quality of artemether-lumefantrine preparations and artemether injections in Cape Coast Metropolis, Ghana, showed that 7 (87.5%) of the 8 brands (6 tablets, 2 suspensions) and all 2 artemether injections passed the International Pharmacopoeia content test [12]. A new validated high performance liquid chromatography method used to analyse the content of 24 artemether-lumefantrine tablets and powders for reconstitution into paediatric suspensions obtained in Ghana showed that all 4 samples which failed (16.7%) were powders for reconstitution into suspensions with two (8.3%) of the samples showing unacceptably higher levels of 222% and 756% artemether [13]. The analysis of microbial load of seven brands of multivitamin syrups marketed in Maiduguri, Nigeria, using the pour-plate method showed that one brand (14.3%) contained the pathogenic bacteria Salmonella spp.…”

Stability indicating Ultra Performance Liquid Chromatography method development and validation for simultaneous estimation of artemether and lumefantrine in bulk and pharmaceutical dosage form

“…Literature review [7][8][9][10][11][12][13][14][15][16][17][18][19] reveals that different methods RP-HPLC, UV, LCMS for its analysis in formulations. Hence our present plan is to develop a new, sensitive, robust& accurate method for its analysis in formulation, after a detailed study, a new UPLC method was decided to be developed and validated as per ICH norms 5,6 .…”