Method development for the simultaneous determination and quantification of artemether lumefantrine in anti malaria formulation using high performance liquid chromatography
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Date
APR, 2015
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Abstract
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).
Description
A thesis submitted in partial fulfilment
of the requirements for the degree of
Master of Philosophy in Analytical Chemistry.