Reverse Phase HPLC Method for the Analysis of Entacapone in Pharmaceutical Dosage Forms

Prakash.S Sarsambi, D.Gowrisankar

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 30C. The detection was carried out at 305nm and the calibration curve was linear in the range of 5 to 30g/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.
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.
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; 4m).
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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