Abstract
Artemisinin-based combination therapies (ACTs) are recommended for the treatment of uncomplicated falciparum malaria. Artemisinin derivatives are potent, rapidly acting antimalarias that reduce gametocyte carriage and patient infectivity; the sustained use of artesunate – amodiaquine reduced falciparum malaria transmission and progression of drug resistance. High efficacy of artemisinin-based combinations (artesunate plus amodiaquine) was observed in areas where malaria is endemic. This paper describes a routine, simple, precise, economical and reproducible thin layer chromatographic technique for the detection of artesunate and amodiaquine in tablet dosage form. Chromatographic separation was performed on glass silica gel plates (20 × 20 cm), paraffin – n-hexane (2:3 v/v) and ethylacetate – toluene (2.5:47.5 V/V) as mobile phases. Artesunate exhibited a detection limit of 0.001 mg/ml, while that of amodiaquine was 0.05 mg/ml. The two drugs were satisfactorily resolved with mean Rf values of 0.04 ± 0.03 and 0.06 ± 0.07 for artesunate and amodiaquine, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (0.001 – 6.0 and 0.05 – 6.0 mg/ml for artesunate and amodiaquine), precision (intraday RSD 10.68 – 25.78% and interday RSD 10.68 – 20.17 for artesunate, and intraday RSD 8.25 – 37.26% and inter day RSD 8.25 – 19.74% for amodiaquine) and specificity, in accordance with International Conference for Harmonization (ICH) guidelines. The method developed can be used for the analysis of ten or more formulation on a single plate and is a rapid and cost-effective quality-control tool for routine analysis of artesunate and amodiaquine as the parent drug and in tablet formulations. Key words: Artemisin based combination therapy (ACT), malaria, falciparum, artesunate, amodiaquine.
Highlights
More than 600 million people worldwide are infected with malaria (WHO, 2003) and an average of 1 to 2 million die every year, most of them are below the age of five
This paper describes a routine, simple, precise, economical and reproducible thin layer chromatographic technique for the detection of artesunate and amodiaquine in tablet dosage form
The accuracy and reliability of the method was assessed by evaluation of linearity (0.001 – 6.0 and 0.05 – 6.0 mg/ml for artesunate and amodiaquine), precision and specificity, in accordance with International Conference for Harmonization (ICH) guidelines
Summary
More than 600 million people worldwide are infected with malaria (WHO, 2003) and an average of 1 to 2 million die every year, most of them are below the age of five. The emergence of parasite strains resistant to chloroquine and other classical drugs was at the origin of the comeback of malaria (>200 million people are infected each year and there are >1 million deaths) (White et al, 1999). Several derivatives have been developed by adding ether, ester or other substituents to the hydroxyl group of dihydroartemisinin These semisynthetic derivatives include water soluble derivatives, sodium artesunate and artelinic acid and the oil-soluble derivatives, artemether and arteether. Clinical studies have shown that artemisinin derivatives are highly potent, rapidly acting and well-tolerated blood schizontocides, resulting in short parasite clearance times as compared to other antimalarial drugs. Artemisinin derivatives are highly effective against P. falciparum isolates that are resistant to other drugs These derivatives are indicated for the emergency treatment of severe and complicated falciparum malarial by parenteral administration and for the oral treatment of uncomplicated multidrug-resistant malaria. The purpose of this research was to establish and validate, in accordance with International Conference on Harmoni-zation (ICH) guidelines, a routine, simple, precise, economical and reproducible thin layer chromatographic technique for the detection of artesunate and amodiaquine in commercial antimalarial drugs
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