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Asian Journal of Pharmaceutical Analysis
Year : 2017, Volume : 7, Issue : 1
First page : ( 1) Last page : ( 5)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2017.00001.1

A New Analytical method Validation and Quantification of Entacapone and its Related Substance in bulk Drug Product by HPLC

Kumar G.1, Patrudu T.B.2,*, Rao Tentu Nageswara1, Rao M.V. Basaveswara1

1Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh India

2Department of Chemistry, GITAM University, Hyderabad Campus, Telangana India

*Corresponding Author E-mail: tnraochemistry@gmail.com

Online published on 18 September, 2017.


A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of entacapone and its related impurities are (N, N diethyl cyano acetamide), (3, 4 Dihydroxy 5-Nitro benzaldehyde) and (2-Z)-2-Cyano-3-(3, 4-Dihydroxy-5-nitrophenyl)N, N-diethyl-2propenamide. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Phenomenex Luna column employing Acetonitrile: HPLC Water in the ratio of 50:50 (v/v) as mobile phase with isocratic at flow rate 0.9 mL/min was chosen. Three impurities were eluted within 15 minutes. The column temperature was maintained at 30°C and a detector wavelength of 210 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Accuracy, limit of detection and Limit of quantification.



HPLC, Method validation, related impurities, entacapone, LOQ, LOD.


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