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Abstract: A simple, rapid and reproducible high
performance reversed phase liquid chromatographic method
has been developed for the determination of Entacapone
in bulk drug samples and pharmaceutical dosage forms
using phenomenex, C-18 column. The mobile phase consists
of potassium dihydrogen phosphate and acetonitrile in
the ratio of 50:50 v/v respectively and was pumped at
rate of 0.8ml/min at 30°C. The detection was carried out
at 305nm and the calibration curve was linear in the
range of 5 to 30µg/ml. The method was statistically
validated for its linearity, precision and accuracy. The
intra-day and inter-day variation was found to be less
than 1% showing high precision of the assay method. The
proposed RP-HPLC method may be used for determining
Entacapone in bulk drug samples or in pharmaceutical
formulations.
Introduction
Entacapone is chemically
(2E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-
propenamide. Entacapone is a (COMT) inhibitor used as an
adjunct in the drug treatment of patients with
Parkinson’s disease. Literature survey reveals that few
methods like determination of Entacapone glycuronides in
plasma serum and blood by HPLC. It is also characterized
in rat plasma by (LC-MS-MS), HPLC method for the
quantification of Entacapone in human plasma, Validation
of U.V. spectrophotometric method in tablets using
experimental design of plackett Burman for Roubstness
evaluation and comparison with HPLC have been reported.
The aim of this study is to develop a simple, sensitive,
rapid precise and accurate RP-HPLC method for
determination of Entacapone in pharmaceutical dosage
forms.
Experimental
Instrumentation
Quantitative HPLC was performed on shimadzu prominence
Isocratic HPLC system with LC 20 AT pump, SPD-20A
detector, spinchrom CFR software column (Phenomenex C18,
250 x 4.6 mm; 4µm).
Chemical and Reagent
Pure sample of Entacapone was obtained as gift sample
from Intas laboratories, Ahmedabad, India. Acetonitrile
(HPLC grade), Potassium Dihydrogen Phosphate (AR grade),
and Methanol (HPLC grade Qualigens). The commercial
available Entacom tablet claimed to contain 200 mg of
drug were procured from local Market.
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