Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
46, Number 5, May/June 2008, pp. 430-435
Computer–Assisted Optimization and Validation
of LC Analysis of Trimetazidine Dihydrochloride and Its Impurities
Mirjana B. Medenica1, Darko P. Ivanovic2,
Igor B. Popovic3, Andjelija M. Malenovic2,
and Biljana S. Jancic2 1Faculty of Pharmacy, Department of Physical Chemistry, Vojvode
Stepe 450, 11000 Belgrade, Serbia and Montenegro;
2Faculty of
Pharmacy, Department of Drug Analysis, Vojvode Stepe 450, 11000
Belgrade, Serbia and Montenegro; 3Medicines and Medical Devices
Agency of Serbia, Vojvode Stepe 458, 11000 Belgrade, Serbia and
Montenegro
Trimetazidine dihydrochloride is an anti-anginal
drug, which possesses protective properties against ischemia
inducing heart damage. In this paper, a new procedure for liquid
chromatographic analysis was successfully developed, optimized,
and applied in assessment of trimetazidine dihydrochloride content
and its impurities, Y-145, Y-235, and Y-234 at most 1.0%, 0.2%,
and 0.2%, respectively, in commercially available pharmaceutical
preparation containing 35 mg of trimetazidine dihydrochloride.
The retention behavior of trimetazidine dihydrochloride and its
impurities is investigated by using several stationary and mobile
phases to settle a simple, sensitive, and precise RP-HPLC method.
The separation conditions are optimized by DryLab 2000 Plus Chromatography
Optimization Software version 3.5.00. Separations are performed
on PurospherSTAR RP18 endcapped (150 × 4.6 mm, 5 µm
particle size) column at 20°C with UV detection at 210 nm.
The mobile phase composition is acetonitrile-aqueous phase (10
mmol/L disodium hydrogenphosphate and 2 mmol/L sodium dihydrogen
phosphate, pH 7.6) (30:70 v/v). Afterwards, the method is validated;
the important statistical parameters for selectivity/specificity,
linearity, precision, limit of detection, and quantitation are
defined. The recovery value of the trimetazidine dihydrochloride
is 98.06%, and the content of impurities is 0.23% for Y-145,
less than 0.02% for Y-235, and less than 0.01% for Y-234. In
addition, this method is used for analyzing trimetazidine dihydrochloride
and its impurities in pharmaceuticals and bulk drug.
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