Volume No. :   7

Issue No. :  1

Year :  2017

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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



Address:   G. Kumar1, T.B. Patrudu2*, Tentu Nageswara Rao1, M.V. Basaveswara Rao1
1Department of Chemistry, Krishna University, Machilipatnam, A.P., India.
2Department of Chemistry, GITAM University, Hyderabad Campus, Telangana India.
*Corresponding Author
DOI No: 10.5958/2231-5675.2017.00001.1

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-2-propenamide. 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 30oC 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.
KEYWORDS:
HPLC, Method validation, related impurities, entacapone, LOQ, LOD
Cite:
A New Analytical method Validation and Quantification of Entacapone and its Related Substance in bulk G. Kumar, T.B. Patrudu, Tentu Nageswara Rao, M.V. Basaveswara Rao. Drug Product by HPLC. Asian J. Pharm. Ana. 2017; 7(1): 1-5.
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