Abstract
As serious but neglected public health problems, poor quality medicines, i.e. for antimalarial medicines, urged to be fought. One of the approaches is to consider the analytical chemistry and separative techniques. In this study, a generic liquid chromatographic method was firstly developed for the purpose of screening 8 antimalarial active ingredients, namely amodiaquine (AQ), piperaquine (PPQ), sulfalene (SL), pyrimethamine (PM), lumefantrine (LF), artesunate (AS), artemether (AM) and dihydroartemisinine (DHA) by applying DoE/DS optimization strategy. Since the method was not totally satisfying in terms of peak separation, further experiments were undergone applying the same development strategy while splitting the 8 ingredients into five groups. Excellent prediction was observed prior to correlation between retention times of predicted and observed separation conditions. Then, a successful geometric transfer was realized to reduce the analysis time focusing on the simultaneous quantification of two WHO’s recommended ACTs in anti-malarial fixed-dose combination (AM-LF and AS-AQ) in tablets. The optimal separation was achieved using an isocratic elution of methanol-ammonium formate buffer (pH 2.8; 10 mM) (82.5:17.5, v/v) at 0.6 ml/min through a C18 column (100 mm × 3.5 mm, 3.5 μm) thermostated at 25℃. After a successful validation stage based on the total error approach, the method was applied to determine the content of AM/LF or AS/AQ in seven brands of antimalarial tablets currently marketed in West, Central and East Africa. Satisfying results were obtained compared to the claimed contents.
Highlights
Poor quality medicines are serious but neglected public health problems
Poor-quality antimalarials that contain sub-therapeutic amounts of active ingredient increase the risk of malaria drug resistance, undoing the significant gains in malaria control seen in the last decade [2]
WHO recommends that all persons of all ages in all epidemiological settings with suspected malaria should receive a parasitological confirmation of diagnosis by either microscopy or rapid diagnostic test (RDT), and that uncomplicated Plasmodium falciparum malaria should be treated with an artemisinin-based combination therapy (ACT) [2]
Summary
Poor quality medicines are serious but neglected public health problems. Anti-infective medicines are afflicted [1]. Poor-quality antimalarials that contain sub-therapeutic amounts of active ingredient increase the risk of malaria drug resistance, undoing the significant gains in malaria control seen in the last decade [2]. As resistance develops to known medicines, it is necessary to commercialize new ones or to use the existing medicines in combination for example in case of malaria infection with Plasmodium falciparum. The use of two or more drugs with different action mechanism is recommended to provide adequate cure rate and delay any development of resistance [3]. WHO recommends that all persons of all ages in all epidemiological settings with suspected malaria should receive a parasitological confirmation of diagnosis by either microscopy or rapid diagnostic test (RDT), and that uncomplicated Plasmodium falciparum malaria should be treated with an artemisinin-based combination therapy (ACT) [2]
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