SPECTROPHOTOMETRIC DETERMINATION AND STABILITY STUDIES OF ARTEMETHER IN ARTEMETHER-LUMEFANTRINE SUSPENSIONS MARKETTED IN ZARIA, NIGERIA.
SPECTROPHOTOMETRIC DETERMINATION AND STABILITY STUDIES OF ARTEMETHER IN ARTEMETHER-LUMEFANTRINE SUSPENSIONS MARKETTED IN ZARIA, NIGERIA.
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Date
2015-10
Authors
YUSUF, Maryam Talatu
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Abstract
The increasing use of artemether-lumefantrine combination as an effective treatment
for resistant malaria demands the need for analytical methods for the quality control
of these drugs in tablets and suspensions. Though some UV Spectrophotometric
methods have been developed for quantification of artemether in various biological
fluids and formulations, they require strainous heating conditions which is a
limitation. This limitation coupled with non-availability of HPLC hence the need to
develop and validate a simple method for the quantification of artemether in
peadiatric suspensions. In this work, we report the method developed by reacting
artemether solution in methanol with concentrated HCl for 30 minutes to obtain an
α,β-unsaturated ketone which was scanned with a UV Spectrophotometer. The
method developed obeyed Beers law in the range 20 – 120 µg/ml, slope (y); 0.01 0,
intercept (x) 0.193, correlation coefficient (r) 0.9987, λmax 260 nm, precision (%
CV); 2, Accuracy (% Er); 2.67 and a recovery of 97%. The detection and
quantification Limit (µg/ml) are 0.14 and 0.58 respectively. The developed method
was successfully applied in the assay of five brands of artemether-lumefantrine
suspensions with 98-101.6% content, and comparism of the means of the assay results
of the method and the IP (2008) method showed no statistically significant difference
(P<0.05). Stability studies of the standard artemether suspension prepared and five
different brands of artemether/lumefantrine powders for suspension was carried out
by extracting artemether with methanol from the suspensions and analyzing it using
the developed method. The content of artemether over 14 days study period ranged
between 98.5-102% and this showed that the suspensions are stable under ambient
conditions for upto 14 days after reconstitution with bottled table water. The results of
the study suggested that the developed method could be used interchangeably in
analysis, and that co-formulation of artemether with lumefantrine has no effect on the
stability of artemether.
Description
A DISSERTATION SUBMITTED TO THE SCHOOL OF POSTGRAUATE
STUDIES, AHMADU BELLO UNIVERSITY, ZARIA
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE
AWARD OF A MASTER DEGREE IN PHARMACEUTICAL AND
MEDICINAL CHEMISTRY.
DEPARTMENT OF PHARMACEUTICAL AND MEDICINAL CHEMISTRY,
FACULTY OF PHARMACEUTICAL SCIENCES, AHMADU BELLO
UNIVERSITY, ZARIA, NIGERIA.
Keywords
SPECTROPHOTOMETRIC DETERMINATION,, STABILITY STUDIES,, ARTEMETHER,, ARTEMETHER-LUMEFANTRINE SUSPENSIONS,, MARKETTED,, ZARIA,, NIGERIA