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Research Article
Development and
Validation of a Dissolution Test Method for Artemether
and Lumefantrine in Tablets
P Umapathi1*, J Ayyappan2 and S
Darlin Quine3
1Department
of Analytical Research and Development, Micro Labs Ltd,
67/68-A, Third Phase, Peenya Industrial Area, Bangalore
560 058, 2SASTRA University, Thanjavur,
Tamil
Nadu, 3PG
and Research Department of Chemistry, Government Arts
College,
Chidambaram, India
For
correspondence:
E-mail:
umpy04@yahoo.com
Tel: +91-80-28379197
Received: 5
March 2011 Revised
accepted: 6
September 2011
Tropical
Journal of Pharmaceutical Research, Oct 2011;
10(5): 643-653
http://dx.doi.org/10.4314/tjpr.v10i5.14
Abstract
Purpose:
To develop and validate a dissolution test method for
dissolution release of artemether and lumefantrine from
tablets.
Methods:
A single dissolution method for evaluating the in vitro
release of artemether and lumefantrine from tablets was
developed and validated. The method comprised of a
dissolution medium of 1000 ml of 2 %w/v of Myrj 52 in
0.005M HCl per vessel with the paddle rotating at 100
rpm for 120 min. The dissolution samples were analysed
using a Waters HPLC system with Waters symmetry column
(C-18 column of 250mm x 4.6mm i.d., 5 µ particle size).
The mobile phase was a mixture of 20 volumes of 0.5 %v/v
of triethylamine in water (adjusted to a pH of 3.0 with
orthophosphoric acid) and 80 volumes of acetonitrile.
The detection wavelength was set at 216 nm and 100 µl of
each sample was injected. The HPLC method used for the
determination of drug release was validated for the
parameters of accuracy, precision, linearity,
specificity, filter validation, solution stability and
robustness.
Results:
The dissolution test provided sink conditions for
artemether and lumefantrine and was able to discriminate
between tablet formulations of different hardness and
different composition. Application of Mann-Whitney U
test for significant difference between samples at
various time points during the dissolution test yielded
z values > 1.96 (1.96 = critical z value at p = 0.05)
for the various formulations tested, indicating the
discriminatory power of the dissolution test.
Conclusion:
This validated dissolution
test may be used as a single dissolution test for
artemether and luminfantrine in tablet formulations.
Keywords:
Artemether, Lumefantrine, Tablet formulations, Single
dissolution test, HPLC . |
