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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.

Abstract

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.

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Keywords

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

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