Method development for the simultaneous determination and quantification of artemether lumefantrine in anti malaria formulation using high performance liquid chromatography

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APR, 2015
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Artemether lumefantrine has been used as a first line treatment for uncomplicated Plasmodium falciparum malaria in Ghana since 2004. In this study, a High Performance Liquid Chromatography(HPLC) method was developed and validated. The developed method was used to simultaneously determine the quantity of artemether and lumefantrine in various fixed dose tablets obtained from pharmaceutical and chemical shops in the Kintampo North Municipality. The optimized chromatographic conditions were a Jasco HPLC system equipped with C18 reverse phase column (Ultracarb 3μ ODS (20)) with methanol and phosphate buffer (72:28) pH 2.8 as the mobile phase. The flow rate was 2.7ml/min and detection was by means of a UV detector set to 222nm. The isocratic mode of elution was employed. The retention time of lumefantrine was 5.22 ± 0.19 minutes. And that for artemether was 4.19 ± 0.22. The method was validated by evaluation of different parameters such as accuracy, precision, linearity, ruggedness and robustness. The percentage recovery for artemether and lumefantrine ranged between 99.18-100.19 and 99.96-100.07, respectively. Six brands of artemether-lumefantrine fixed-dose combination tablets (two local and four foreign) from selected chemical shops and pharmaceutical shops in the Kintampo- North Municipality were analyzed. Of the six brands of artemether lumefantrine fixed-dose combination tablets analyzed, all passed with respect to their artemether and lumefantrine content using the developed HPLC method. The percent recovery for the local brands ranges from 93.5 to 99.2% and from 91.3 to 97.2% for artemether and lumefantrine respectively. And from 92.05 to 105.0% and 95.8 99.9% for the foreign brands for artemether and lumefantrine respectively, which complies with the International Pharmacopoeia range of (90110).
A thesis submitted in partial fulfilment of the requirements for the degree of Master of Philosophy in Analytical Chemistry.